Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone (NCT00398502)

01

Study 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.

02

Conditions studied

Metahdone-maintenance Subjects

03

In context

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

05

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)

Interventions

DrugMOA-728

06

What researchers measure

Primary outcomes

Pharmacokinetics and Pharmacodynamics

07

Study locations

1 site

Gainesville, Florida 32608, United States

08

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID: NCT00398502
Lead sponsor: Bausch Health Americas, Inc.
First posted: Nov 10, 2006
Start date: Oct 2006
Completion: Dec 2006
Last update: Nov 25, 2019

Study contacts

Jeff Cohn

study director · Bausch Health Americas, Inc.

View the source record on ClinicalTrials.gov ↗

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