Trial Outcomes & Findings for A Safety Study of PTI-125 in Healthy Volunteers (NCT NCT03784300)
NCT ID: NCT03784300
Last Updated: 2021-05-10
Results Overview
The peak drug concentration will be obtained directly from the data without interpolation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Results posted on
2021-05-10
Participant Flow
Participant milestones
| Measure |
50 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of PTI-125 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
38.2 Years
n=5 Participants
|
31.8 Years
n=7 Participants
|
35.3 Years
n=5 Participants
|
31.8 Years
n=4 Participants
|
35.8 Years
n=21 Participants
|
31.8 Years
n=10 Participants
|
35.3 Years
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The peak drug concentration will be obtained directly from the data without interpolation.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
315 ng/mL
Standard Deviation 96.6
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
550 ng/mL
Standard Deviation 146
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
1240 ng/mL
Standard Deviation 276
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The time to peak drug concentration will be obtained directly from the data without interpolation
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) (Tmax)
|
1.56 hours
Standard Deviation 0.69
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
1.08 hours
Standard Deviation 0.48
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
1.28 hours
Standard Deviation 0.57
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Time to Last Quantifiable Plasma Concentration (Tlast)
|
44.0 hours
Standard Deviation 16.4
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
46.0 hours
Standard Deviation 4.6
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
50.00 hours
Standard Deviation 11.8
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Last Quantifiable Plasma Concentration (Clast)
|
1.04 ng/mL
Standard Deviation 0.495
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.795 ng/mL
Standard Deviation 0.294
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.806 ng/mL
Standard Deviation 0.292
|
NA ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The elimination rate constant (λz) will be calculated.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Elimination Rate Constant (λz)
|
0.141 1/hour
Standard Deviation 0.0539
|
NA 1/hour
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.157 1/hour
Standard Deviation 0.0155
|
NA 1/hour
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.144 1/hour
Standard Deviation 0.0516
|
NA 1/hour
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The terminal elimination half-life (T1/2) will be calculated.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Termination Elimination Half-Life (T1/2)
|
6.05 hours
Standard Deviation 3.87
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
4.45 hours
Standard Deviation 0.39
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
5.93 hours
Standard Deviation 3.87
|
NA hours
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC)
|
2040 h*ng/mL
Standard Deviation 893
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
3130 h*ng/mL
Standard Deviation 1150
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
8130 h*ng/mL
Standard Deviation 1530
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Area Under the Curve to Infinity (AUCinf)
|
2180 h*ng/mL
Standard Deviation 897
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
3260 h*ng/mL
Standard Deviation 1150
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
8250 h*ng/mL
Standard Deviation 1530
|
NA h*ng/mL
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The percentage of AUCinf based on extrapolation (AUCextrap\[%\]).
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).
|
0.410 percent extrapolated
Standard Deviation 0.187
|
NA percent extrapolated
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.151 percent extrapolated
Standard Deviation 0.0366
|
NA percent extrapolated
Standard Deviation NA
Pk values N/A for placebo subjects
|
0.144 percent extrapolated
Standard Deviation 0.0156
|
NA percent extrapolated
Standard Deviation NA
Pk values N/A for placebo subjects
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
The apparent oral clearance will be calculated.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Oral Clearance (Cl/F)
|
25.7 (L/h)
Standard Deviation 8.42
|
NA (L/h)
Standard Deviation NA
Pk value not available as these are placebo patients
|
33.0 (L/h)
Standard Deviation 8.16
|
NA (L/h)
Standard Deviation NA
Pk value not available as these are placebo patients
|
24.9 (L/h)
Standard Deviation 4.53
|
NA (L/h)
Standard Deviation NA
Pk value not available as these are placebo patients
|
PRIMARY outcome
Timeframe: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.Population: Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.
Vz/F, apparent volume of distribution will be calculated.
Outcome measures
| Measure |
50 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 Participants
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 Participants
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz/F)
|
199 (L)
Standard Deviation 64.9
|
NA (L)
Standard Deviation NA
Pk value not available as these are placebo patients
|
215 (L)
Standard Deviation 64.8
|
NA (L)
Standard Deviation NA
Pk value not available as these are placebo patients
|
214 (L)
Standard Deviation 154
|
NA (L)
Standard Deviation NA
Pk value not available as these are placebo patients
|
Adverse Events
50 mg PTI-125
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 mg PTI-125 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg PTI-125
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 mg PTI-125 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg PTI-125
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mg PTI-125 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg PTI-125
n=6 participants at risk
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
50 mg PTI-125 Placebo
n=2 participants at risk
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
50 mg PTI-125: PTI-125 50 mg Oral Solution
|
100 mg PTI-125
n=6 participants at risk
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
100 mg PTI-125 Placebo
n=2 participants at risk
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
100 mg PTI-125: PTI-125 100 mg Oral Solution
|
200 mg PTI-125
n=6 participants at risk
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
200 mg PTI-125 Placebo
n=2 participants at risk
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
200 mg PTI-125: PTI-125 200 mg Oral Solution
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
lightheadedness
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/2 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
|
Musculoskeletal and connective tissue disorders
transient musculoskeletal wall pain
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/2 • 7 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/2 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/2 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60