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NCT01366365 · ClinicalTrials.gov registry record · Phase 1

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

A Phase 1 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT01366365 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 28 participants.

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The verdict

NCT01366365, a Phase 1 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

Interventions

  • DRUG placebo
  • DRUG methylnaltrexone

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2006-10
Est. Completion 2006-11
Phase Phase 1

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT01366365

The ClinicalTrials.gov registry entry for NCT01366365 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01366365 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01366365 about?

NCT01366365 is a clinical study titled "Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide". This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerabilit...

What is the current status of trial NCT01366365?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2006-10. Estimated completion is 2006-11.

What interventions are being tested in trial NCT01366365?

The interventions under investigation include: placebo (DRUG), methylnaltrexone (DRUG).

Who is sponsoring clinical trial NCT01366365?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.