NCT00800319

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

ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-02-01
• Completion: 2009-06-01
• First posted: 2008-12-02
• Last updated: 2011-08-22

Locations

1 site across 1 country: United States