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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800319
• Other study ID #: ALK33-001
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2008
• Last updated: August 19, 2011
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
• Placebo
Volume matched placebo; oral solution; single dose

Locations

Country	Name	City	State
United States	Quintiles Phase One Services	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentrations (Cmax) of RDC-0313		12 weeks	No
Secondary	Clinically significant abnormal laboratory findings		12 weeks	Yes