Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398502
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : July 25, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
Primary: To determine the relative bioavailability of MOA-728, an investigational drug, administered orally in both the capsule and tablet formulations to methadone maintenance subjects.Secondary: To assess the pharmacodynamic effect of MOA-728 administered both orally and subcutaneously to methadone maintenance subjects using the oral-cecal transit time.

Condition or disease Intervention/treatment Phase
Metahdone-maintenance Subjects Drug: MOA-728 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, 3-period Crossover Study to Determine the Relative Bioavailability of Two Oral Formulations of MOA-728 and to Compare the Pharmacodynamics of the Two Oral Formulations of MOA-728 and the Subcutaneous Formulation in Subjects on Stable Methadone Maintenance
Study Start Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone
U.S. FDA Resources

Primary Outcome Measures :
  1. Pharmacokinetics and Pharmacodynamics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Men or nonlactating and nonpregnant women, aged 18 to 65 years, inclusive. Women of nonchildbearing potential must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year. Women of childbearing potential must be using an acceptable nonhormonal method of contraception (intrauterine device [IUD], diaphragm, or condom with spermicidal jelly or foam, or abstinence) for a period of at least 1 month before and after dose administration. All women must have negative pregnancy test results within 48 hours before the start of the first test article administration.
  • Body mass index in the range of 18 to 35 kg/m² and body weight ≥50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
  • Subjects with positive results for HBsAg, and/or HCV antibodies may be enrolled if their bilirubin and serum albumin values are within normal limits and their liver function tests are within 1.2 times the upper limit of the normal range.
  • A history of methadone treatment for at least 1 month before day -1 and have a positive drug test for methadone.
  • No concomitant medication with the exception of stable doses of anxiolytic agents, antidepressants, Seroquel, occasional sleep medications, and drugs or supplements required to enhance or maintain regulation of bowel movements (must be stopped for the 72 hours before the first dose of test article administration in each period).
  • Must have a high probability for compliance with and completion of the study.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398502

United States, Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00398502     History of Changes
Other Study ID Numbers: 3200A3-105
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents