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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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

Key facts

Study ID

NCT00800319

Run by

Alkermes, Inc.

People needed

16

Starts

2008-12-01

Expected to finish

2009-06-01

Last updated by the study team

2011-08-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 - 65 years of age
• Body mass index of 19-30 kg/m2 at screening
• If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
• If subject is male, he must agree to reduce the risk of a female partner becoming pregnant

You may not qualify if…

• Pregnancy and/or currently breastfeeding
• Clinically significant medical condition or observed abnormalities
• Clinically significant illness within 30 days of the first study drug administration
• History of opioid dependence
• Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
• Positive resolut for any serology test performed at screening
• Use of alcohol-, caffeine-, or xanthine-containing products
• Tobacco use within 90 days before the first study drug administration
• Participation in a clinical trial within 30 days before screening
• Requirement of a special diet other than vegetarian, or significant food allergy or intolerance

Where it is running

• Quintiles Phase One Services — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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