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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alkermes

ClinicalTrials.gov Identifier:

NCT00800319

First received: December 1, 2008

Last updated: August 19, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2008

Last Updated Date

August 19, 2011

Start Date ^ICMJE

December 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum plasma concentrations (Cmax) of RDC-0313 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00800319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinically significant abnormal laboratory findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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-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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Alcohol Dependence

Intervention ^ICMJE

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

Study Arm (s)

Experimental: RDC-0313, 5mg
5 mg of RDC-0313; single dose

Intervention: Drug: RDC-0313
Experimental: RDC-0313, 15 mg
15 mg RDC-0313; single dose

Intervention: Drug: RDC-0313
Experimental: RDC-0313, 25mg
25 mg RDC-0313; single dose

Intervention: Drug: RDC-0313
Experimental: RDC-0313, 50 mg
50 mg RDC-0313; single dose

Intervention: Drug: RDC-0313
Experimental: RDC-0313, 75 mg
75 mg RDC-0313; single dose

Intervention: Drug: RDC-0313
Placebo Comparator: Placebo
volume-match placebo; single dose

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00800319

Other Study ID Numbers ^ICMJE

ALK33-001

Has Data Monitoring Committee

Yes

Responsible Party

Alkermes

Study Sponsor ^ICMJE

Alkermes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Philip T. Leese, MD

Quintiles Phase One Services

Information Provided By

Alkermes

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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