Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Phase 1

Completed

• Conditions: Normal Volunteers
• Interventions: Drug: MNTX tablet (Formulation 1); Drug: MNTX tablet (Formulation 2)

• Registration Number: NCT01366352
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Weight between 55 and 85 kg
2. In good health, based on history, physical examination, and appropriate laboratory and diagnostic tests at screening, with no evidence of clinically significant chronic medical condition
3. Non-smokers.

Exclusion Criteria

1. History of evidence of cardiovascular, gastrointestinal, hepatic, musculoskeletal, neurological, pulmonary, renal, or other significant chronic illness
2. History of asthma, allergic skin rash, significant allergy, or other immunologic disorder
3. Consumption of barbiturates or other inducers or inhibitors of CYP450
4. History or suspicion of alcohol or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	MNTX tablet (Formulation 1)	MNTX tablet
Arm 2	MNTX tablet (Formulation 2)	MNTX tablet

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations	7 days	To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

Secondary Outcome Measures

Name	Time	Method
Half-life of MNTX administered as two different oral formulations	7 days	To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations	7 days	To determine and compare the plasma pharmacokinetics, relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations	7 days	To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations	7 days	To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations	7 days	To determine and compare relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States