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ALK33-001: A Study of RDC-0313 Administered to Healthy Adults

NCT00800319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-08-22

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.

Conditions

  • Alcohol Dependence

Interventions

DRUG

RDC-0313

Oral solution given in 5, 15, 25, 50, and 75 mg single doses

DRUG

Placebo

Volume matched placebo; oral solution; single dose

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Philip T. Leese, MD · Quintiles Phase One Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-02-28
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00800319 on ClinicalTrials.gov