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COMPLETED Phase 1

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

NCT01366378 · View on ClinicalTrials.gov ↗

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

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01366378

The ClinicalTrials.gov registry entry for NCT01366378 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01366378 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01366378?

The interventions under investigation include: methylnaltrexone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01366378?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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