Tolerance and Pharmacokinetics Study of MNTX Tablets

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01366339
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Condition or Disease	Intervention/Treatment	Phase
Normal Healthy Volunteers	Drug: Oral methylnaltrexone; Drug: Oral placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Dec 1, 2003
• Actual Study Completion Date: Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Oral methylnaltrexone	Drug: Oral methylnaltrexone
Experimental: Arm 2 Oral methylnaltrexone	Drug: Oral methylnaltrexone
Experimental: Arm 3 Oral methylnaltrexone	Drug: Oral methylnaltrexone
Placebo Comparator: Arm 4 Oral placebo	Drug: Oral placebo

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) of oral doses of MNTX [7 days]

   To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

Secondary Outcome Measures

1. Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX [7 days]

   To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

2. Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX [7 days]

   To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

3. Half-life of oral doses of MNTX [7 days]

   To determine PK, dose proportionality, and urinary excretion of single, oral doses 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 with no evidence of a clinically significant chronic medical condition

3. Non-Smokers.

Exclusion Criteria:

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder

2. Known or suspected hypersensitivity to opioids or opioid antagonists

3. 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: NCT01366339
• Other Study ID Numbers: MNTX 1201
• 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