Tolerance and Pharmacokinetics Study of MNTX Tablets

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Normal Healthy Volunteers

Treatments: Drug: Oral methylnaltrexone; Drug: Oral placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366339

MNTX 1201

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Oral methylnaltrexone

Treatment:

Drug: Oral methylnaltrexone

Arm 2

Experimental group

Description:

Oral methylnaltrexone

Treatment:

Drug: Oral methylnaltrexone

Arm 3

Experimental group

Description:

Oral methylnaltrexone

Treatment:

Drug: Oral methylnaltrexone

Arm 4

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Oral placebo