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Completed

NCT Number: NCT01366339

Tolerance and Pharmacokinetics Study of MNTX Tablets

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.

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Key information

Conditions

Normal Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weight between 55 and 85 kg
  • In good health with no evidence of a clinically significant chronic medical condition
  • Non-Smokers.

Exclusion criteria

  • History of asthma, allergic skin rash, significant allergy or other immunologic disorder
  • Known or suspected hypersensitivity to opioids or opioid antagonists
  • History or suspicion of alcohol or drug abuse.

Treatment and study plan

Oral methylnaltrexone

Drug

oral placebo

Drug

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of oral doses of MNTX

    Time frame: 7 days

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

Secondary outcomes

  1. Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX

    Time frame: 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

    Time frame: 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

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jun 6, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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