Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CPP-115 · 1 trial · 1 indication
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 ...
CPP-115 is an investigational small molecule being developed for the treatment of cocaine dependency. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetic profile in healthy volunteers.
CPP-115 is being developed by Catalyst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CPRX. The company is conducting clinical research on this investigational drug for the treatment of cocaine dependency.
CPP-115 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains in the early stages of clinical testing for cocaine dependency.
CPP-115 has been studied in one completed Phase 1 clinical trial, registered as NCT01493596. The trial was a safety, tolerability, and pharmacokinetic study conducted in the United States. It enrolled 55 healthy male volunteers aged 18 years and older, and the study was randomized, double-blind, and controlled.
CPP-115 is a distinct investigational drug candidate developed by Catalyst Pharmaceuticals. It is not known to be the same as any other marketed or approved medication. The drug is being studied specifically for its potential use in treating cocaine dependency.