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NCT01366326 · ClinicalTrials.gov registry record · Phase 1

Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

A Phase 1 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01366326 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 20 participants.

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The verdict

NCT01366326, a Phase 1 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.

Interventions

  • DRUG Methylnaltrexone bromide

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-07
Est. Completion 2010-08
Phase Phase 1

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT01366326

The ClinicalTrials.gov registry entry for NCT01366326 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 1 intervention - of which Methylnaltrexone bromide is the first listed.

NCT01366326 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01366326 about?

NCT01366326 is a clinical study titled "Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects". MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.

What is the current status of trial NCT01366326?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-07. Estimated completion is 2010-08.

What interventions are being tested in trial NCT01366326?

The interventions under investigation include: Methylnaltrexone bromide (DRUG).

Who is sponsoring clinical trial NCT01366326?

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.