CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
CPP-115 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01493596
NCT01493596Phase 1Completed

A Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of CPP-115 Solution Administered Orally to Healthy Volunteers

Catalyst Pharmaceuticals, Inc.·interventional·Posted Dec 16, 2011·Updated Apr 20, 2021

In Brief

A Phase 1 clinical trial evaluating CPP-115 and Placebo for Cocaine Dependency. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Primary Objective: • To evaluate the safety and tolerability of ascending single oral doses of CPP-115 Secondary Objective: • To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.5 years ago

Interventions

CPP-115drug

Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.

Placebodrug

An equal volume of water mixed with juice will be administered.