Trial Outcomes & Findings for A Study of Fosmanogepix in Healthy Adult Chinese Subjects (NCT NCT06961708)
NCT ID: NCT06961708
Last Updated: 2026-04-06
Results Overview
PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose
Results posted on
2026-04-06
Participant Flow
The study was conducted at one site in China
Participant milestones
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)
Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7
|
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)
The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7.
|
Multiple-dose Part-2 (Placebo)
Subjects received placebo matching the respective Part-2 Cohort treatments
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
9
|
9
|
4
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
7
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)
Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7
|
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)
The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7.
|
Multiple-dose Part-2 (Placebo)
Subjects received placebo matching the respective Part-2 Cohort treatments
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Did not receive study drug due to safety finding pre-dose
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Fosmanogepix in Healthy Adult Chinese Subjects
Baseline characteristics by cohort
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
n=8 Participants
Subjects received placebo matching the respective Part-1 Cohort treatments
|
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)
n=8 Participants
Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7
|
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)
n=8 Participants
The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7.
|
Multiple-dose Part-2 (Placebo)
n=4 Participants
Subjects received placebo matching the respective Part-2 Cohort treatments
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
32.3 years
STANDARD_DEVIATION 3.83 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 7.13 • n=10 Participants
|
38.8 years
STANDARD_DEVIATION 5.00 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 5.10 • n=11 Participants
|
31.1 years
STANDARD_DEVIATION 5.91 • n=13 Participants
|
33.9 years
STANDARD_DEVIATION 6.38 • n=48 Participants
|
29.5 years
STANDARD_DEVIATION 6.14 • n=6 Participants
|
33.2 years
STANDARD_DEVIATION 5.84 • n=2 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=11 Participants
|
8 Participants
n=13 Participants
|
6 Participants
n=48 Participants
|
3 Participants
n=6 Participants
|
43 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=11 Participants
|
8 Participants
n=13 Participants
|
8 Participants
n=48 Participants
|
4 Participants
n=6 Participants
|
52 Participants
n=2 Participants
|
|
Height (cm)
|
166.8 Cm
STANDARD_DEVIATION 8.84 • n=5 Participants
|
160.7 Cm
STANDARD_DEVIATION 10.67 • n=5 Participants
|
168.2 Cm
STANDARD_DEVIATION 6.11 • n=10 Participants
|
162.3 Cm
STANDARD_DEVIATION 4.97 • n=5 Participants
|
171.3 Cm
STANDARD_DEVIATION 4.37 • n=11 Participants
|
166.9 Cm
STANDARD_DEVIATION 7.59 • n=13 Participants
|
172.9 Cm
STANDARD_DEVIATION 7.70 • n=48 Participants
|
168.5 Cm
STANDARD_DEVIATION 7.00 • n=6 Participants
|
167.5 Cm
STANDARD_DEVIATION 7.88 • n=2 Participants
|
|
Weight (kg)
|
62.30 Kg
STANDARD_DEVIATION 8.26 • n=5 Participants
|
62.00 Kg
STANDARD_DEVIATION 10.71 • n=5 Participants
|
67.97 Kg
STANDARD_DEVIATION 9.14 • n=10 Participants
|
65.28 Kg
STANDARD_DEVIATION 6.51 • n=5 Participants
|
71.53 Kg
STANDARD_DEVIATION 8.84 • n=11 Participants
|
65.13 Kg
STANDARD_DEVIATION 6.73 • n=13 Participants
|
66.88 Kg
STANDARD_DEVIATION 8.69 • n=48 Participants
|
60.70 Kg
STANDARD_DEVIATION 6.73 • n=6 Participants
|
65.70 Kg
STANDARD_DEVIATION 8.45 • n=2 Participants
|
|
BMI (kg/m2)
|
22.32 Kg/m2
STANDARD_DEVIATION 1.60 • n=5 Participants
|
23.87 Kg/m2
STANDARD_DEVIATION 1.72 • n=5 Participants
|
24.05 Kg/m2
STANDARD_DEVIATION 3.05 • n=10 Participants
|
24.82 Kg/m2
STANDARD_DEVIATION 2.90 • n=5 Participants
|
24.34 Kg/m2
STANDARD_DEVIATION 2.38 • n=11 Participants
|
23.40 Kg/m2
STANDARD_DEVIATION 2.00 • n=13 Participants
|
22.31 Kg/m2
STANDARD_DEVIATION 2.04 • n=48 Participants
|
21.35 Kg/m2
STANDARD_DEVIATION 1.10 • n=6 Participants
|
23.39 Kg/m2
STANDARD_DEVIATION 2.31 • n=2 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
Pharmacokinetic (PK) parameter Cmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1
|
5750 ng/mL
Geometric Coefficient of Variation 39.5
|
10865 ng/mL
Geometric Coefficient of Variation 12.9
|
8343 ng/mL
Geometric Coefficient of Variation 31.1
|
13874 ng/mL
Geometric Coefficient of Variation 18.0
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
PK parameter Tmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1
|
2.50 hour
Interval 2.0 to 3.0
|
3.00 hour
Interval 2.0 to 4.0
|
2.96 hour
Interval 2.85 to 3.05
|
2.99 hour
Interval 2.87 to 3.05
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
PK parameter AUC 24 for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1
|
49823 h*ng/mL
Geometric Coefficient of Variation 17.3
|
89822 h*ng/mL
Geometric Coefficient of Variation 25.3
|
76270 h*ng/mL
Geometric Coefficient of Variation 32.3
|
132743 h*ng/mL
Geometric Coefficient of Variation 28.2
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
PK parameter AUClast for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1
|
148314 h*ng/mL
Geometric Coefficient of Variation 12.1
|
278079 h*ng/mL
Geometric Coefficient of Variation 16.8
|
257783 h*ng/mL
Geometric Coefficient of Variation 30.5
|
407819 h*ng/mL
Geometric Coefficient of Variation 12.6
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1
|
156539 h*ng/mL
Geometric Coefficient of Variation 14.4
|
296639 h*ng/mL
Geometric Coefficient of Variation 17.7
|
266920 h*ng/mL
Geometric Coefficient of Variation 33.4
|
440974 h*ng/mL
Geometric Coefficient of Variation 9.7
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7Population: PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix
PK parameter Cmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=7 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=8 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2
|
14665 ng/mL
Geometric Coefficient of Variation 17.1
|
16459 ng/mL
Geometric Coefficient of Variation 7.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7Population: PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix
PK parameter Tmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=7 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=8 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2
|
2.90 hour
Interval 2.87 to 2.97
|
3.50 hour
Interval 2.0 to 6.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7Population: PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix
PK parameter AUCtau after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=7 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=8 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2
|
224722 h*ng/mL
Geometric Coefficient of Variation 24.2
|
258780 h*ng/mL
Geometric Coefficient of Variation 8.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 3 hours postdosePopulation: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group
The fraction of unbound manogepix has been assessed after single dose administration (oral / IV)
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Fraction of Unbound Manogepix in Plasma in Part 1
|
0.109 percentage
Geometric Coefficient of Variation 11.4
|
0.105 percentage
Geometric Coefficient of Variation 22.3
|
0.192 percentage
Geometric Coefficient of Variation 27.1
|
0.226 percentage
Geometric Coefficient of Variation 8.2
|
—
|
SECONDARY outcome
Timeframe: Up to 36 daysPopulation: Safety set consisted of all randomized subjects who had received at least one dose of study drug. Subjects were to be analyzed according to the drug they actually received
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 Participants
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
n=8 Participants
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
None TEAE
|
1 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
Any study drug-related TEAE
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
Any treatment-emergent serious adverse event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
Any study drug-related TEAE leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 daysPopulation: Safety set consisted of all randomized subjects who had received at least one dose of study drug. Subjects were to be analyzed according to the drug they actually received
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Outcome measures
| Measure |
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=8 Participants
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=8 Participants
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=4 Participants
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
Subjects received placebo matching the respective Part-1 Cohort treatments
|
|---|---|---|---|---|---|
|
Number of Subjects With TEAE in Part-2
Any study drug-related TEAE not leading to treatment discontinuation
|
4 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With TEAE in Part-2
Any study drug-related TEAE leading to treatment discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With TEAE in Part-2
Any treatment-emergent SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With TEAE in Part-2
None TEAE
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
Adverse Events
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Single-dose Part -1 (Cohort 1, Oral 400 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Single-dose Part -1 (Cohort 1, Oral 800 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Single-dose Part-1 (Cohort 2, IV 600 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-dose Part-1 (Cohort 2, IV 1000 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single-dose Part-1 (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Multiple-dose Part-2 (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)
n=8 participants at risk
The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7.
|
Single-dose Part -1 (Cohort 1, Oral 400 mg)
n=6 participants at risk
Subjects received 400 mg fosmanogepix by oral administration
|
Single-dose Part -1 (Cohort 1, Oral 800 mg)
n=6 participants at risk
Subjects received 800 mg fosmanogepix by oral administration
|
Single-dose Part-1 (Cohort 2, IV 600 mg)
n=6 participants at risk
Subjects received 600 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Cohort 2, IV 1000 mg)
n=6 participants at risk
Subjects received 1000 mg fosmanogepix by IV infusion
|
Single-dose Part-1 (Placebo)
n=8 participants at risk
Subjects received placebo matching the respective Part-1 Cohort treatments
|
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)
n=8 participants at risk
Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7
|
Multiple-dose Part-2 (Placebo)
n=4 participants at risk
Subjects received placebo matching the respective Part-2 Cohort treatments
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Creatinine renal clearance decreased
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
16.7%
1/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
Neutrophil count increased
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
16.7%
1/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Nervous system disorders
Dizziness
|
62.5%
5/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
50.0%
3/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
16.7%
1/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Nervous system disorders
Drooling
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
16.7%
1/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
37.5%
3/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
2/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
33.3%
2/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
33.3%
2/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Gastrointestinal disorders
Regurgitation
|
25.0%
2/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
25.0%
1/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/6 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
12.5%
1/8 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
0.00%
0/4 • Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
|
Additional Information
Thomas Kaindl, MD
Basilea Pharmaceutica International Ltd, Allschwil
Phone: +41615671505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place