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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01493596 | A Safety, Tolerability and Pharmacokinetic Study of CPP-115 | PHASE1 | COMPLETED | 55 | — | — | Dec 1, 2011 | Aug 1, 2012 | Apr 20, 2021 | 1 | United States |
Number of subjects with clinically significant changes in vital signs, ECG abnormalities changes of cardiac rhythm, serious or severe AEs, and/or clinically significant changes in clinical laboratory evaluations.
| Arm | Type | Description |
|---|---|---|
| CPP-115 Dose 1 | OTHER | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 2 | OTHER | 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 3 | OTHER | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 4 | OTHER | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 5 | OTHER | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 6 | OTHER | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| Name | Type | Description |
|---|---|---|
| CPP-115 | DRUG | Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. |
| Placebo | DRUG | An equal volume of water mixed with juice will be administered. |
Inclusion Criteria: 1. Willing and able to give written informed consent and comply with study procedures and requirements. 2. Males, age 18 to 65 years. 3. Body Mass Index between 19 and 32 kg/m2. 4. Normal systolic blood pressure (BP \[90-140 mmHg\]), diastolic BP (50 90 mmHg) and heart rate (HR ...