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NCT01366378 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Adult Subjects, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT01366378 is a Phase 1 study of Healthy Adult Subjects that has completed, run by Bausch Health Americas. The registered enrollment target is 18 participants, below the 38-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01366378, a Phase 1 study of Healthy Adult Subjects, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Interventions

  • DRUG methylnaltrexone

Study Locations (1)

New York

  • Progenics Pharmaceuticals, Inc. - Tarrytown

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2007-01
Est. Completion 2007-02
Phase Phase 1

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT01366378

The ClinicalTrials.gov registry entry for NCT01366378 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 38-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (53% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Adult Subjects appearing as the primary indexed condition, and to 1 intervention - of which methylnaltrexone is the first listed.

NCT01366378 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01366378 about?

NCT01366378 is a clinical study titled "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.

What is the current status of trial NCT01366378?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2007-01. Estimated completion is 2007-02.

What conditions does trial NCT01366378 study?

This clinical trial studies the following conditions: Healthy Adult Subjects.

What interventions are being tested in trial NCT01366378?

The interventions under investigation include: methylnaltrexone (DRUG).

Who is sponsoring clinical trial NCT01366378?

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

Where is trial NCT01366378 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.