Trial Outcomes & Findings for A FIH Study to Investigate the Safety, Tolerability and PK of P218 (NCT NCT02885506)
NCT ID: NCT02885506
Last Updated: 2019-08-01
Results Overview
Number of participants with adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
During 11 days post administration of a single oral dose of P218 to healthy volunteers
Results posted on
2019-08-01
Participant Flow
Participant milestones
| Measure |
Cohort 1
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fed - Fasted
250 mg P218 oral administration under fed then fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fasted - Fed
250 mg P218 oral administration under fasted then fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
0
|
0
|
|
Part A
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
0
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The study contained two parts, and separate participants were included in each part.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
n=14 Participants
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fed - Fasted
n=4 Participants
A single oral dose of 250 mg of P218 under fed then fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fasted - Fed
n=4 Participants
A single oral dose of 250 mg of P218 under fasted then fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part A
|
32.2 years
STANDARD_DEVIATION 8.8 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
26.8 years
STANDARD_DEVIATION 6.9 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
29.7 years
STANDARD_DEVIATION 8 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
27.2 years
STANDARD_DEVIATION 7.7 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
26.2 years
STANDARD_DEVIATION 6.2 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
27.5 years
STANDARD_DEVIATION 4.1 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
28.7 years
STANDARD_DEVIATION 7.6 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
25.4 years
STANDARD_DEVIATION 6.2 • n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
27.6 years
STANDARD_DEVIATION 6.8 • n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Age, Continuous
Part B
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
23 years
STANDARD_DEVIATION 5 • n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
32 years
STANDARD_DEVIATION 6.2 • n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
27.5 years
STANDARD_DEVIATION 7.1 • n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Sex: Female, Male
Part A · Female
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
0 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Sex: Female, Male
Part A · Male
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
14 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
56 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Sex: Female, Male
Part B · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Sex: Female, Male
Part B · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
4 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
8 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · American Indian or Alaska Native
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
0 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · Asian
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
2 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
6 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
0 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · Black or African American
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
3 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
8 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · White
|
5 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
3 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
4 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
3 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
3 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
5 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
5 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
8 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
36 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · More than one race
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
6 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part A · Unknown or Not Reported
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
0 Participants
n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
1 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
2 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
3 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
6 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Race (NIH/OMB)
Part B · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
0 Participants
n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Body Mass Index (BMI)
Part A
|
23.2 kg/m²
STANDARD_DEVIATION 1.44 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
22.48 kg/m²
STANDARD_DEVIATION 2 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
23 kg/m²
STANDARD_DEVIATION 1.89 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
23.15 kg/m²
STANDARD_DEVIATION 2.04 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
23 kg/m²
STANDARD_DEVIATION 2.43 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
22.35 kg/m²
STANDARD_DEVIATION 1.74 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
22.57 kg/m²
STANDARD_DEVIATION 2.36 • n=6 Participants • The study contained two parts, and separate participants were included in each part.
|
21.91 kg/m²
STANDARD_DEVIATION 1.87 • n=14 Participants • The study contained two parts, and separate participants were included in each part.
|
—
|
—
|
22.59 kg/m²
STANDARD_DEVIATION 1.91 • n=56 Participants • The study contained two parts, and separate participants were included in each part.
|
|
Body Mass Index (BMI)
Part B
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.65 kg/m²
STANDARD_DEVIATION 2.52 • n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
24.65 kg/m²
STANDARD_DEVIATION 1.29 • n=4 Participants • The study contained two parts, and separate participants were included in each part.
|
23.15 kg/m²
STANDARD_DEVIATION 2.45 • n=8 Participants • The study contained two parts, and separate participants were included in each part.
|
PRIMARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: In Part A, forty-two subjects received P218 at single doses of 10, 30, 100, 250, 500, 750 or 1000 mg and 14 subjects received placebo (two each per dose level). In Part B, four subjects received a single dose of 250 mg when fasted in Period 1 and fed in Period 2, four other subjects received 250 mg when fed in Period 1 and fasted in Period 2.
Number of participants with adverse events
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
n=14 Participants
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of P218: Incidence, Severity and Relationship to the Investigational Product of Observed and Self-reported Adverse Events
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUClast
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)
|
129.799 ng.h/mL
Standard Deviation 34.394
|
443.774 ng.h/mL
Standard Deviation 91.790
|
1610.743 ng.h/mL
Standard Deviation 351.794
|
4007.975 ng.h/mL
Standard Deviation 1017.207
|
8101.229 ng.h/mL
Standard Deviation 2905.479
|
13592.017 ng.h/mL
Standard Deviation 2405.709
|
18286.115 ng.h/mL
Standard Deviation 5915.260
|
—
|
3409.601 ng.h/mL
Standard Deviation 1062.776
|
3397.972 ng.h/mL
Standard Deviation 1377.368
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data available from all completed cohorts for P218. Hence no data analysed for Pooled Placebo cohort. Subject 202 in cohort 2 (30 mg) reported a half-life estimate of 19.2 hours, considered outlying with regard to the remainder of the cohort with a geometric mean half-life of 3.13 hrs.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUCinf
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=5 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=5 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=5 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
133.561 h*ng/mL
Standard Deviation 37.598
|
417.496 h*ng/mL
Standard Deviation 62.144
|
1621.068 h*ng/mL
Standard Deviation 390.845
|
4027.181 h*ng/mL
Standard Deviation 1014.917
|
8126.550 h*ng/mL
Standard Deviation 2904.536
|
13782.492 h*ng/mL
Standard Deviation 2614.899
|
18445.724 h*ng/mL
Standard Deviation 5774.322
|
—
|
3449.478 h*ng/mL
Standard Deviation 1381.293
|
3440.498 h*ng/mL
Standard Deviation 1055.743
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Cmax
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax)
|
72.567 ng/mL
Standard Deviation 38.099
|
208.167 ng/mL
Standard Deviation 51.573
|
1000.333 ng/mL
Standard Deviation 393.963
|
2120.000 ng/mL
Standard Deviation 373.310
|
4441.667 ng/mL
Standard Deviation 1799.493
|
6251.667 ng/mL
Standard Deviation 1894.027
|
9005.000 ng/mL
Standard Deviation 3055.943
|
—
|
1271.000 ng/mL
Standard Deviation 814.827
|
1785.625 ng/mL
Standard Deviation 924.390
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Tmax
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)
|
1.092 hours
Standard Deviation 0.490
|
1.167 hours
Standard Deviation 0.408
|
0.917 hours
Standard Deviation 0.585
|
1.172 hours
Standard Deviation 0.684
|
1.419 hours
Standard Deviation 0.668
|
1.589 hours
Standard Deviation 1.284
|
1.169 hours
Standard Deviation 0.407
|
—
|
2.500 hours
Standard Deviation 1.309
|
1.188 hours
Standard Deviation 0.530
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: t1/2
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=5 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=5 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=5 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2)
|
3.525 hours
Standard Deviation 2.238
|
8.538 hours
Standard Deviation 6.492
|
17.615 hours
Standard Deviation 4.382
|
12.014 hours
Standard Deviation 9.829
|
14.359 hours
Standard Deviation 7.666
|
18.314 hours
Standard Deviation 11.527
|
24.407 hours
Standard Deviation 19.509
|
—
|
26.007 hours
Standard Deviation 12.678
|
23.386 hours
Standard Deviation 15.689
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: CL/F (for parent only)
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=5 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=5 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=5 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) (for Parent Only)
|
79.978 L/h
Standard Deviation 22.039
|
73.397 L/h
Standard Deviation 12.995
|
65.323 L/h
Standard Deviation 19.235
|
65.292 L/h
Standard Deviation 15.468
|
67.082 L/h
Standard Deviation 19.245
|
56.220 L/h
Standard Deviation 12.022
|
57.812 L/h
Standard Deviation 14.131
|
—
|
83598.839 L/h
Standard Deviation 35344.849
|
78876.051 L/h
Standard Deviation 24043.587
|
SECONDARY outcome
Timeframe: During 11 days post administration of a single oral dose of P218 to healthy volunteersPopulation: Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Vz/F (for parent only).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=5 Participants
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=5 Participants
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 Participants
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 Participants
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=5 Participants
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 Participants
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 Participants
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase After Oral Administration (Vz/F) (for Parent Only).
|
371.147 L
Standard Deviation 141.081
|
856.018 L
Standard Deviation 563.080
|
1701.469 L
Standard Deviation 860.918
|
1130.341 L
Standard Deviation 976.613
|
1383.792 L
Standard Deviation 1006.067
|
1618.045 L
Standard Deviation 1431.351
|
2141.443 L
Standard Deviation 2200.839
|
—
|
2960.939 L
Standard Deviation 1263.797
|
2561.542 L
Standard Deviation 1407.629
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fasted Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fed Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
10 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 2
n=6 participants at risk
30 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 3
n=6 participants at risk
100 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 4
n=6 participants at risk
250 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 5
n=6 participants at risk
500 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 6
n=6 participants at risk
750 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Cohort 7
n=6 participants at risk
1000 mg P218 oral administration
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Pooled Placebo
n=14 participants at risk
Placebo capsule oral administration
Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
|
Fasted Cohort
n=8 participants at risk
A single oral dose of 250 mg of P218 under fasted conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
Fed Cohort
n=8 participants at risk
A single oral dose of 250 mg of P218 under fed conditions.
Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
PRESYNCOPE
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
33.3%
2/6 • Number of events 2 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Gastrointestinal disorders
FAECES SOFT
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
33.3%
2/6 • Number of events 2 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
7.1%
1/14 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
33.3%
2/6 • Number of events 2 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
7.1%
1/14 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
12.5%
1/8 • Number of events 1 • Up to D29 or longer according to half life.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
16.7%
1/6 • Number of events 1 • Up to D29 or longer according to half life.
|
7.1%
1/14 • Number of events 1 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
|
Cardiac disorders
DIZZINESS
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
12.5%
1/8 • Number of events 1 • Up to D29 or longer according to half life.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
12.5%
1/8 • Number of events 1 • Up to D29 or longer according to half life.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/6 • Up to D29 or longer according to half life.
|
0.00%
0/14 • Up to D29 or longer according to half life.
|
0.00%
0/8 • Up to D29 or longer according to half life.
|
12.5%
1/8 • Number of events 1 • Up to D29 or longer according to half life.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Richmond shall not issue or submit any press release for publication without MMV's prior written approval. In recognition that Richmond and the Site Principal Investigator have a responsibility to ensure that results of scientific interest arising from a Clinical Trial are appropriately published and disseminated, Richmond may, upon MMV's written consent which will not be unreasonably withheld, publish Results of a clinical trial carried out under a Project Agreement.
- Publication restrictions are in place
Restriction type: OTHER