Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03784300 | A Safety Study of PTI-125 in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Aug 18, 2017 | Mar 27, 2018 | May 10, 2021 | 1 | United States |
The peak drug concentration will be obtained directly from the data without interpolation.
The time to peak drug concentration will be obtained directly from the data without interpolation
The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.
The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration
The elimination rate constant (λz) will be calculated.
The terminal elimination half-life (T1/2) will be calculated.
The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.
The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.
The percentage of AUCinf based on extrapolation (AUCextrap\[%\]).
The apparent oral clearance will be calculated.
Vz/F, apparent volume of distribution will be calculated.
| Arm | Type | Description |
|---|---|---|
| 50 mg PTI-125 | ACTIVE_COMPARATOR | Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort. |
| 50 mg PTI-125 Placebo | PLACEBO_COMPARATOR | Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort. |
| 100 mg PTI-125 | ACTIVE_COMPARATOR | Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort. |
| 100 mg PTI-125 Placebo | PLACEBO_COMPARATOR | Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort. |
| 200 mg PTI-125 | ACTIVE_COMPARATOR | Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort. |
| 200 mg PTI-125 Placebo | PLACEBO_COMPARATOR | Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort. |
| Name | Type | Description |
|---|---|---|
| 50 mg PTI-125 | DRUG | PTI-125 50 mg Oral Solution |
| 100 mg PTI-125 | DRUG | PTI-125 100 mg Oral Solution |
| 200 mg PTI-125 | DRUG | PTI-125 200 mg Oral Solution |
Inclusion Criteria: * Male or female subjects between 18 and 45 years of age, inclusive. * The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive). * The subject is in good health as determined by medical history and physical examination and clinical laboratory parameters. * The subj...