Completed

NCT Number: NCT00398502

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

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.

Completed

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Key information

Conditions

Metahdone-maintenance Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MOA-728

Drug

Primary outcomes

Pharmacokinetics and Pharmacodynamics

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2006
First posted: Nov 10, 2006
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.