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A Safety, Tolerability and Pharmacokinetic Study of CPP-115

NCT01493596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-04-20

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Mardik Donikyan, DO · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493596 on ClinicalTrials.gov