Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metahdone-Maintenance Subjects
Intervention: MOA-728 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-availability Study
Primary outcome: Pharmacokinetics and Pharmacodynamics
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Gainesville, Florida 32608, United States
Additional Information
Starting date: October 2006
Ending date: December 2006
Last updated: December 3, 2007
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