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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00800319
First received: December 1, 2008
Last updated: August 19, 2011
Last verified: August 2011

December 1, 2008
August 19, 2011
December 2008
February 2009   (final data collection date for primary outcome measure)
Maximum plasma concentrations (Cmax) of RDC-0313 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800319 on ClinicalTrials.gov Archive Site
Clinically significant abnormal laboratory findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00800319
ALK33-001
Yes
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Principal Investigator: Philip T. Leese, MD Quintiles Phase One Services
Alkermes, Inc.
August 2011

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