Status:
COMPLETED
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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-031...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00800319
Start Date
December 1 2008
End Date
June 1 2009
Last Update
August 22 2011
Active Locations (1)
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1
Quintiles Phase One Services
Overland Park, Kansas, United States, 66211