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
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: RDC-0313
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

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

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

Enrollment: 16
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RDC-0313, 5mg
5 mg of RDC-0313; single dose
Drug: RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Experimental: RDC-0313, 15 mg
15 mg RDC-0313; single dose
Drug: RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Experimental: RDC-0313, 25mg
25 mg RDC-0313; single dose
Drug: RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Experimental: RDC-0313, 50 mg
50 mg RDC-0313; single dose
Drug: RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Experimental: RDC-0313, 75 mg
75 mg RDC-0313; single dose
Drug: RDC-0313
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Placebo Comparator: Placebo
volume-match placebo; single dose
Drug: Placebo
Volume matched placebo; oral solution; single dose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800319

Locations
United States, Kansas
Quintiles Phase One Services
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Principal Investigator: Philip T. Leese, MD Quintiles Phase One Services
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00800319     History of Changes
Other Study ID Numbers: ALK33-001
Study First Received: December 1, 2008
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
Alcohol dependence
Opioid antagonist
RDC-0313

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014