Trial Outcomes & Findings for First in Man Clinical Trial of Emodepside (BAY 44-4400) (NCT NCT02661178)
NCT ID: NCT02661178
Last Updated: 2020-04-13
Results Overview
Deaths, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
Up to 14 days post dose (may be extended to 21 days)
Results posted on
2020-04-13
Participant Flow
79 healthy subjects were randomized and received study drug. Protocol Enrollment reflects the total number of participants enrolled in both Part 1 (63 participants) and Part 2 (16 participants).
Participant milestones
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 1mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
1
|
5
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
12
|
4
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
0
|
5
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
12
|
4
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
2
|
2
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
2
|
2
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 1mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Totals were calculated seperately for Parts 1 and 2
Baseline characteristics by cohort
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, AE Follow-up Arm (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part 1
|
23 years
STANDARD_DEVIATION 0 • n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
38.6 years
STANDARD_DEVIATION 10.06 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
34.8 years
STANDARD_DEVIATION 9.20 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
29.3 years
STANDARD_DEVIATION 8.12 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
36.8 years
STANDARD_DEVIATION 10.69 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
34.2 years
STANDARD_DEVIATION 10.55 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
32.8 years
STANDARD_DEVIATION 9.75 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
31.3 years
STANDARD_DEVIATION 8.91 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
30.8 years
STANDARD_DEVIATION 10.83 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
30.7 years
STANDARD_DEVIATION 7.46 • n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
28.0 years
STANDARD_DEVIATION 3.56 • n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
32.4 years
STANDARD_DEVIATION 8.89 • n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Age, Continuous
Part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
27.7 years
STANDARD_DEVIATION 7.34 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
38.5 years
STANDARD_DEVIATION 10.67 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
51.5 years
STANDARD_DEVIATION 0.71 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
40 years
STANDARD_DEVIATION 11.31 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
38.3 years
STANDARD_DEVIATION 13.67 • n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Sex: Female, Male
Part 1 · Female
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Sex: Female, Male
Part 1 · Male
|
1 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
12 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
4 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
63 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Sex: Female, Male
Part 2 · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Sex: Female, Male
Part 2 · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
16 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 1 · Hispanic or Latino
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
1 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
1 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
1 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
3 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 1 · Not Hispanic or Latino
|
1 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
11 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
3 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
60 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 1 · Unknown or Not Reported
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 2 · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
1 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 2 · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
15 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Ethnicity (NIH/OMB)
Part 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · American Indian or Alaska Native
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · Asian
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · Black or African American
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · White
|
1 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
5 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
12 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
4 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
63 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · More than one race
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 1 · Unknown or Not Reported
|
0 Participants
n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
0 Participants
n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
6 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
2 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
16 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Race (NIH/OMB)
Part 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
0 Participants
n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Height
Part 1
|
173 cm
STANDARD_DEVIATION 0 • n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
176.8 cm
STANDARD_DEVIATION 4.87 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
179.8 cm
STANDARD_DEVIATION 6.24 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
175.5 cm
STANDARD_DEVIATION 5.82 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
177.2 cm
STANDARD_DEVIATION 10.87 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
177.2 cm
STANDARD_DEVIATION 3.54 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
179.0 cm
STANDARD_DEVIATION 7.51 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
179.5 cm
STANDARD_DEVIATION 7.45 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
183.3 cm
STANDARD_DEVIATION 7.63 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
180.0 cm
STANDARD_DEVIATION 7.98 • n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
183.3 cm
STANDARD_DEVIATION 2.99 • n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
179.1 cm
STANDARD_DEVIATION 6.89 • n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Height
Part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
183.2 cm
STANDARD_DEVIATION 6.37 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
176.0 cm
STANDARD_DEVIATION 5.22 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
178 cm
STANDARD_DEVIATION 8.49 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
181 cm
STANDARD_DEVIATION 4.24 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
179.6 cm
STANDARD_DEVIATION 6.28 • n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Weight
Part 1
|
72.00 kg
STANDARD_DEVIATION 0 • n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
70.64 kg
STANDARD_DEVIATION 6.815 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
75.47 kg
STANDARD_DEVIATION 11.331 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
75.83 kg
STANDARD_DEVIATION 3.506 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
76.56 kg
STANDARD_DEVIATION 13.197 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
74.80 kg
STANDARD_DEVIATION 11.383 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
81.93 kg
STANDARD_DEVIATION 10.397 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
81.73 kg
STANDARD_DEVIATION 9.075 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
83.27 kg
STANDARD_DEVIATION 11.267 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
79.52 kg
STANDARD_DEVIATION 10.130 • n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
85.15 kg
STANDARD_DEVIATION 7.217 • n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
78.43 kg
STANDARD_DEVIATION 9.931 • n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
Weight
Part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
82.20 kg
STANDARD_DEVIATION 7.979 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
82.65 kg
STANDARD_DEVIATION 13.598 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
72.8 kg
STANDARD_DEVIATION 1.98 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
83.7 kg
STANDARD_DEVIATION 24.75 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
81.38 kg
STANDARD_DEVIATION 11.636 • n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
BMI
Part 1
|
24.10 kg/m^2
STANDARD_DEVIATION 0 • n=1 Participants • Totals were calculated seperately for Parts 1 and 2
|
22.60 kg/m^2
STANDARD_DEVIATION 2.117 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
23.30 kg/m^2
STANDARD_DEVIATION 2.683 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
24.65 kg/m^2
STANDARD_DEVIATION 1.162 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
24.20 kg/m^2
STANDARD_DEVIATION 1.707 • n=5 Participants • Totals were calculated seperately for Parts 1 and 2
|
23.75 kg/m^2
STANDARD_DEVIATION 2.868 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
25.55 kg/m^2
STANDARD_DEVIATION 2.651 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
25.43 kg/m^2
STANDARD_DEVIATION 3.169 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
24.72 kg/m^2
STANDARD_DEVIATION 2.613 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
24.49 kg/m^2
STANDARD_DEVIATION 2.131 • n=12 Participants • Totals were calculated seperately for Parts 1 and 2
|
25.38 kg/m^2
STANDARD_DEVIATION 2.291 • n=4 Participants • Totals were calculated seperately for Parts 1 and 2
|
—
|
—
|
—
|
—
|
24.41 kg/m^2
STANDARD_DEVIATION 2.356 • n=63 Participants • Totals were calculated seperately for Parts 1 and 2
|
|
BMI
Part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24.5 kg/m^2
STANDARD_DEVIATION 2.137 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
26.55 kg/m^2
STANDARD_DEVIATION 3.213 • n=6 Participants • Totals were calculated seperately for Parts 1 and 2
|
23.1 kg/m^2
STANDARD_DEVIATION 2.83 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
25.4 kg/m^2
STANDARD_DEVIATION 6.36 • n=2 Participants • Totals were calculated seperately for Parts 1 and 2
|
25.21 kg/m^2
STANDARD_DEVIATION 3.117 • n=16 Participants • Totals were calculated seperately for Parts 1 and 2
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group. In Part 2, n=16 (n=16 subjects completed)
Deaths, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Adverse Events
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Adverse Events
Subjects with SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Adverse Events
Subjects with TEAE
|
1 participants
|
3 participants
|
0 participants
|
3 participants
|
3 participants
|
5 participants
|
3 participants
|
2 participants
|
5 participants
|
3 participants
|
5 participants
|
5 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.
Abnormal or clinically significant neurological examination findings during the study or reported as an AE
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Abnormal neurological examination
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Neurological examination reported as AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Abnormal physcial examination
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Physical and Neurological Examination Findings
Physical examination reported as AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.
Vital signs included heart rate, systolic and diastolic blood pressure,
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Vital Signs
Clinically significant change in heart rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Vital Signs
Clinically significant change in systolic BP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Vital Signs
Clinically significant change in diastolic BP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.
The following variables were recorded in 12-lead ECGs and extracted from continuous 12-lead ECG recordings: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by 12-lead ECG
Notable changes in ventricular rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by 12-lead ECG
Notable changes in PR interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by 12-lead ECG
Notable changes in QRS interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by 12-lead ECG
Notable changes in QTcB
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by 12-lead ECG
Notable changes in QTcF interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.
Clinical laboratory parameters included hematology, biochemistry, serology and coagulation in blood samples and urinalysis in urine samples
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 Participants
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 Participants
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinically significant hematological changes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinically significant biochemical changes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinically significant serological changes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinically significant coagulation changes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Clinical Laboratory Parameters
Clinically significant urinalysis changes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 14 days post dose (may be extended to 21 days)Population: AEs were determined in the Safety Population. Opthalmology examinations were only performed for the Emodepside 40mg group (n=6) and the corresponding placebo group (n=2)
Subjects attended a specialist eye hospital for ophthalmology assessments by a Consultant Ophthalmologist. Opthalmology assessments included:ocular symptoms, past ocular history, auto-refraction, best corrected distance visual acuity, color vision assessment, amsler grid assessment, ocular alignment and ocular motility assessment, confrontation visual field assessment, slit lamp examination (anterior segment), intraocular pressure (Goldmann Tonometry), optical coherence scanning of tomography, post mydriatic ocular media (at Screening visit 2 only) and retinal examination with slit lamp and lens.
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=6 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=2 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only
Clinically significant occular symptoms
|
4 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only
Clinically significant best corrected vis acuity
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only
Clinically significant changes in remaining exams
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0 participants
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0 participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: It is unacceptable to use AUCinf data if\>40% of the AUC has been extrapolated.This is in line with literature(Gabrielson\&Weiner, 2000).The AUCinf values with\<20% of the area extrapolated (reliable results) have not been summarised in the tables because n is either 1 or 2 per treatment (n=2 only for 1m solution).
The area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞)
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=1 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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The AUC∞ of Emodepside in Plasma
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
NA h*ng/ml
Standard Deviation NA
see explanation above
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: It is unacceptable to use AUCinf data if\>40% of the AUC has been extrapolated.This is in line with literature(Gabrielson\&Weiner, 2000).The AUCinf values with\<20% of the area extrapolated (reliable results) have not been summarised in the tables because n is either 1 or 2 per treatment (n=2 only for 1m solution).
Dose-normalized area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞/D), calculated as AUC∞/Dose administered.
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
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Emodepside 40mg Solution, Fasted, (Part 2)
n=1 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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The AUC∞/D of Emodepside in Plasma
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NA No values calculated
see explanation above
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NA No values calculated
see explanation above
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NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
NA No values calculated
see explanation above
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration were summarized using PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Maximum observed plasma concentration (Cmax) was obtained directly from the concentration-time data
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Cmax of Emodepside in Plasma
|
18.6 ng/mL
Geometric Coefficient of Variation 20.8
|
37.6 ng/mL
Geometric Coefficient of Variation 15.5
|
92.1 ng/mL
Geometric Coefficient of Variation 16.2
|
25.7 ng/mL
Geometric Coefficient of Variation 23.9
|
172 ng/mL
Geometric Coefficient of Variation 32.3
|
306 ng/mL
Geometric Coefficient of Variation 28.7
|
30.2 ng/mL
Geometric Coefficient of Variation 62.5
|
595 ng/mL
Geometric Coefficient of Variation 27.9
|
71.9 ng/mL
Geometric Coefficient of Variation 29.6
|
434 ng/mL
Geometric Coefficient of Variation 32.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Dose-normalized observed maximum plasma concentration (Cmax/D) was calculated as Cmax/Dose administered
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Cmax/D of Emodepside in Plasma
|
18.6 (ng/mL)/mg
Geometric Coefficient of Variation 20.8
|
15.0 (ng/mL)/mg
Geometric Coefficient of Variation 15.5
|
18.4 (ng/mL)/mg
Geometric Coefficient of Variation 16.2
|
5.15 (ng/mL)/mg
Geometric Coefficient of Variation 23.9
|
17.2 (ng/mL)/mg
Geometric Coefficient of Variation 32.3
|
15.3 (ng/mL)/mg
Geometric Coefficient of Variation 28.7
|
1.51 (ng/mL)/mg
Geometric Coefficient of Variation 62.5
|
14.9 (ng/mL)/mg
Geometric Coefficient of Variation 27.9
|
71.9 (ng/mL)/mg
Geometric Coefficient of Variation 29.6
|
10.9 (ng/mL)/mg
Geometric Coefficient of Variation 32.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
The observed maximum plasma concentration (Cmax) normalized by dose and body weight was calculated as Cmax/(Dose administered\*body weight)
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Cmax, Norm of Emodepside in Plasma
|
0.265 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 25.1
|
0.203 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 25.2
|
0.244 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 18.4
|
0.0680 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 27.7
|
0.233 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 46.7
|
0.189 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 35.7
|
0.0187 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 69.1
|
0.178 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 36.3
|
0.0882 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 28.9
|
0.133 (ng/mL)/(mg*kg)
Geometric Coefficient of Variation 49.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived)
Time to reach maximum plasma concentration (Tmax) was obtained directly from the concentration-time data
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Tmax of Emodepside in Plasma
|
1.00 Hours
Interval 1.0 to 1.05
|
1.00 Hours
Interval 1.0 to 2.5
|
1.00 Hours
Interval 1.0 to 1.5
|
2.00 Hours
Interval 1.02 to 2.55
|
1.00 Hours
Interval 1.0 to 1.0
|
1.50 Hours
Interval 1.0 to 2.53
|
2.00 Hours
Interval 1.5 to 2.02
|
1.05 Hours
Interval 1.0 to 8.0
|
2.50 Hours
Interval 2.0 to 2.52
|
0.967 Hours
Interval 0.95 to 3.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived)
Terminal half-life (t½), calculated according to the equation t½ = ln2/λz, where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The t½ of Emodepside in Plasma
|
42.7 Hours
Geometric Coefficient of Variation 531
|
449 Hours
Geometric Coefficient of Variation 74.0
|
415 Hours
Geometric Coefficient of Variation 117
|
267 Hours
Geometric Coefficient of Variation 392
|
365 Hours
Geometric Coefficient of Variation 286
|
590 Hours
Geometric Coefficient of Variation 68.1
|
348 Hours
Geometric Coefficient of Variation 171
|
392 Hours
Geometric Coefficient of Variation 31.7
|
531 Hours
Geometric Coefficient of Variation 99.3
|
440 Hours
Geometric Coefficient of Variation 49.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
The mean residence time (MRT) was calculated as MRT = AUMC/AUC∞, where AUMC is the area under the first moment of the concentration-time curve from zero time (pre-dose) extrapolated to infinite time
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The MRT of Emodepside in Plasma
|
52.7 Hours
Geometric Coefficient of Variation 528
|
572 Hours
Geometric Coefficient of Variation 78.8
|
570 Hours
Geometric Coefficient of Variation 92.1
|
337 Hours
Geometric Coefficient of Variation 430
|
533 Hours
Geometric Coefficient of Variation 232
|
757 Hours
Geometric Coefficient of Variation 69.9
|
443 Hours
Geometric Coefficient of Variation 182
|
489 Hours
Geometric Coefficient of Variation 31.4
|
752 Hours
Geometric Coefficient of Variation 91.7
|
569 Hours
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Apparent total clearance from plasma (CL/F) was calculated as CL/F = Dose/AUC∞
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The CL/F of Emodepside in Plasma
|
3.88 L/hour
Geometric Coefficient of Variation 151
|
1.37 L/hour
Geometric Coefficient of Variation 44.1
|
1.34 L/hour
Geometric Coefficient of Variation 57.8
|
4.79 L/hour
Geometric Coefficient of Variation 179
|
1.42 L/hour
Geometric Coefficient of Variation 115
|
1.34 L/hour
Geometric Coefficient of Variation 24.8
|
13.3 L/hour
Geometric Coefficient of Variation 150
|
1.57 L/hour
Geometric Coefficient of Variation 32.6
|
1.42 L/hour
Geometric Coefficient of Variation 57.3
|
1.69 L/hour
Geometric Coefficient of Variation 22.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Area under the plasma concentration-time curve from time zero (pre-dose) to 24 h was calculated using the trapezoidal method
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The AUC 0-24 of Emodepside in Plasma
|
100 h*ng/mL
Geometric Coefficient of Variation 50.4
|
250 h*ng/mL
Geometric Coefficient of Variation 6.50
|
522 h*ng/mL
Geometric Coefficient of Variation 25.8
|
183 h*ng/mL
Geometric Coefficient of Variation 24.3
|
996 h*ng/mL
Geometric Coefficient of Variation 21.2
|
1910 h*ng/mL
Geometric Coefficient of Variation 16.3
|
223 h*ng/mL
Geometric Coefficient of Variation 58.0
|
4110 h*ng/mL
Geometric Coefficient of Variation 33.6
|
673 h*ng/mL
Geometric Coefficient of Variation 26.4
|
3320 h*ng/mL
Geometric Coefficient of Variation 26.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Dose-normalized area under the concentration-time curve (AUC) from time zero (pre-dose) to 24 h was calculated as AUC0-24/Dose administered
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The AUC 0-24/D of Emodepside in Plasma
|
100 (h.ng/mL)/mg)
Geometric Coefficient of Variation 50.4
|
100 (h.ng/mL)/mg)
Geometric Coefficient of Variation 6.50
|
104 (h.ng/mL)/mg)
Geometric Coefficient of Variation 25.8
|
36.5 (h.ng/mL)/mg)
Geometric Coefficient of Variation 24.3
|
99.6 (h.ng/mL)/mg)
Geometric Coefficient of Variation 21.2
|
95.3 (h.ng/mL)/mg)
Geometric Coefficient of Variation 16.3
|
11.2 (h.ng/mL)/mg)
Geometric Coefficient of Variation 58.0
|
103 (h.ng/mL)/mg)
Geometric Coefficient of Variation 33.6
|
67.3 (h.ng/mL)/mg)
Geometric Coefficient of Variation 26.4
|
82.9 (h.ng/mL)/mg)
Geometric Coefficient of Variation 26.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Area under the concentration-time curve from time zero (pre-dose) to 24 h, normalized by dose and body weight (AUC 24, norm) was calculated as AUC0-24/(Dose administered\*body weight)
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The AUC 24, Norm of Emodepside in Plasma
|
1.43 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 58.7
|
1.35 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 17.5
|
1.38 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 27.8
|
0.483 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 28.9
|
1.35 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 33.8
|
1.18 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 27.8
|
0.138 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 66.0
|
1.23 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 42.9
|
0.825 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 30.8
|
1.01 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 45.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
Apparent volume of distribution (Vz/F) was calculated as Vz/F = Dose/(λz × AUC∞), where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Vz/F of Emodepside in Plasma
|
239 Litres
Geometric Coefficient of Variation 88.0
|
885 Litres
Geometric Coefficient of Variation 27.4
|
802 Litres
Geometric Coefficient of Variation 49.1
|
1850 Litres
Geometric Coefficient of Variation 56.1
|
748 Litres
Geometric Coefficient of Variation 68.7
|
1140 Litres
Geometric Coefficient of Variation 47.1
|
6700 Litres
Geometric Coefficient of Variation 40.1
|
888 Litres
Geometric Coefficient of Variation 21.3
|
1090 Litres
Geometric Coefficient of Variation 36.2
|
1070 Litres
Geometric Coefficient of Variation 41.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t), calculated using the linear trapezoidal method for increasing concentrations and the log trapezoidal method for decreasing concentrations
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The AUC Last of Emodepside in Plasma
|
182 h*ng/mL
Geometric Coefficient of Variation 111
|
845 h*ng/mL
Geometric Coefficient of Variation 10.4
|
1700 h*ng/mL
Geometric Coefficient of Variation 24.2
|
501 h*ng/mL
Geometric Coefficient of Variation 76.8
|
3070 h*ng/mL
Geometric Coefficient of Variation 27.7
|
7480 h*ng/mL
Geometric Coefficient of Variation 22.1
|
667 h*ng/mL
Geometric Coefficient of Variation 125
|
16400 h*ng/mL
Geometric Coefficient of Variation 23.6
|
3390 h*ng/mL
Geometric Coefficient of Variation 20.4
|
13800 h*ng/mL
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
The average relative bioavailability (Frel) of the IR tablet was calculated
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frel of the IR (Immediate Release) Tablet of Emodepside
|
35.0 Frel percentage
Interval 26.6 to 46.0
|
11.7 Frel percentage
Interval 7.73 to 17.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).
The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration normalized by dose and body weight (AUClast/(Dose administered\*body weight))
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=5 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=5 Participants
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 Participants
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The AUC Last, Norm of Emodepside in Plasma
|
2.60 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 127
|
4.56 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 19.5
|
4.50 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 27.1
|
1.33 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 78.4
|
4.17 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 42.6
|
4.62 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 30.8
|
0.414 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 138
|
4.91 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 36.5
|
4.16 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 25.5
|
4.21 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 42.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: emodepside assessed in fasted condition: only one cohort (10mg solution) assessed with high fat high calories meal.
Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=6 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect of Food on the Bioavailability (Cmax) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
|
172 ng/ml
Interval 96.7 to 227.0
|
71.9 ng/ml
Interval 47.4 to 109.0
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: From pre-dose until 336h post-dose (may be extended to 504h post-dose)Population: emodepside assessed in fasted condition: only one cohort (10mg solution) assessed with high fat high calories meal.
Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.
Outcome measures
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=6 Participants
No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
|
Emodepside 1mg Solution, Fasted (Part 1)
n=6 Participants
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect of Food on the Bioavailability (AUC24) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only
|
996 ng*h/mL
Interval 753.0 to 1380.0
|
673 ng*h/mL
Interval 520.0 to 982.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
Adverse Events
Emodepside 0.1mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Emodepside 1mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Emodepside 2.5mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Emodepside 5mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Emodepside 5mg Tablet, Fasted (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Emodepside 10mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Emodepside 20mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Emodepside 20mg Tablet, Fasted (Part 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Emodepside 40mg Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Emodepside 10mg Solution, Fed (Part 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Emodepside 40mg Solution, Fasted, (Part 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Solution, Fasted (Part 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Tablet, Fasted (Part 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Solution, Fed (Part 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Solution, Fasted (Part 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Emodepside 0.1mg Solution, Fasted (Part 1)
n=1 participants at risk
Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 1mg Solution, Fasted (Part 1)
n=5 participants at risk
Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 2.5mg Solution, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Solution, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 5mg Tablet, Fasted (Part 1)
n=5 participants at risk
Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Solution, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 20mg Tablet, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 40mg Solution, Fasted (Part 1)
n=6 participants at risk
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Emodepside 10mg Solution, Fed (Part 2)
n=6 participants at risk
Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Emodepside 40mg Solution, Fasted, (Part 2)
n=6 participants at risk
Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 1)
n=12 participants at risk
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Tablet, Fasted (Part 1)
n=4 participants at risk
Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
|
Placebo Solution, Fed (Part 2)
n=2 participants at risk
Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
Placebo Solution, Fasted (Part 2)
n=2 participants at risk
Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
40.0%
2/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
20.0%
1/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
50.0%
3/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
33.3%
2/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
66.7%
4/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
2/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Eye disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
20.0%
1/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
33.3%
2/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
83.3%
5/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
83.3%
5/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
25.0%
1/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Infections and infestations
TEAEs by primary system organ classes (SOCs)
|
100.0%
1/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
83.3%
5/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Musculoskeletal and connective tissue disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
20.0%
1/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
20.0%
1/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Respiratory, thoracic and mediastinal disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
8.3%
1/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Gastrointestinal disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
50.0%
3/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
8.3%
1/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
25.0%
1/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
General disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
33.3%
2/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
50.0%
3/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Injury, poisoning and procedural complications
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
8.3%
1/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
|
Psychiatric disorders
TEAEs by primary system organ classes (SOCs)
|
0.00%
0/1 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
20.0%
1/5 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
16.7%
1/6 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/12 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/4 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
0.00%
0/2 • The AE reporting period for this trial began after subject enrolment in the trial (after signature of informed consent) and ended at the follow-up visit (3 weeks after their dose of study medicine) .
|
Additional Information
Sophie Delhomme
Drugs for Neglected Diseases initiative
Phone: +41229069230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution (HMR) could not make any public communication related to the Results or Trial Subjects, notably, without DNDi's prior written approval. The Institution shall inform DNDi in advance of any media visits to the Clinical Trial site and comply with the guidance provided by DNDi.
- Publication restrictions are in place
Restriction type: OTHER