Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01366352
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Days): 29
• Patients Per Site Per Month: 25.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Volunteers	Drug: MNTX tablet (Formulation 1); Drug: MNTX tablet (Formulation 2)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets: A Double-Blind, Single Dose, Crossover, Phase 1 Study in Normal Volunteers
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Mar 1, 2004
• Actual Study Completion Date: Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 MNTX tablet	Drug: MNTX tablet (Formulation 1)
Experimental: Arm 2 MNTX tablet	Drug: MNTX tablet (Formulation 2)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01366352
• Other Study ID Numbers: MNTX 1202
• First Posted: Jun 6, 2011
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019