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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: ALKS-33

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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