NCT01493596

A Safety, Tolerability and Pharmacokinetic Study of CPP-115

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Catalyst Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Cocaine Dependency

Interventions

Type	Name	Description
DRUG	CPP-115	Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
DRUG	Placebo	An equal volume of water mixed with juice will be administered.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2011-12-16
• Last updated: 2021-04-20
• Results posted: 2021-04-20

Locations

1 site across 1 country: United States