Skip to main content
OpenTrials
Completed

NCT Number: NCT01366378

Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Adult Subjects

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

  • Healthy males and females between the ages of 18 and 45
  • Subjects who are non-smokers
  • Subjects with body weights with range of 154-220 lbs.

Exclusion criteria

  • Females who are pregnant or lactating
  • Subjects with a history of any clinically significant disease or condition affecting a major organ system
  • Subjects with ECG abnormalities
  • Subjects who have tested positive for hepatitis B, hepatitis C or HIV
  • Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
  • Subjects with positive urine results for drugs of abuse.

Treatment and study plan

methylnaltrexone

Drug

Primary outcomes

  1. Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen

    Time frame: 7 days

    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

Secondary outcomes

  1. Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen

    Time frame: 7 days

    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  2. Half-life of MNTX prior to and following a multi-dose cimetidine regimen

    Time frame: 7 days

    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  3. Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen

    Time frame: 7 days

    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  4. Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen

    Time frame: 7 days

    To assess the potential effects of cimetidine on the pharmacokinetics of MNTX

  5. Number of subject with adverse events as measured before, during, and after administration of cimetidine

    Time frame: 7 days

    To assess the potential effects of cimetidine on safety, and tolerability of MNTX

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.