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NCT01366339 · ClinicalTrials.gov registry record · Phase 1
Tolerance and Pharmacokinetics Study of MNTX Tablets
A Phase 1 study of Normal Healthy Volunteers, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01366339 is a Phase 1 study of Normal Healthy Volunteers that has completed, run by Bausch Health Americas. The registered enrollment target is 37 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01366339, a Phase 1 study of Normal Healthy Volunteers, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
Conditions Studied
Interventions
- DRUG Oral placebo
- DRUG Oral methylnaltrexone
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2003-10 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01366339
The ClinicalTrials.gov registry entry for NCT01366339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 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 1 condition, with Normal Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Oral placebo is the first listed.
NCT01366339 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01366339 about?
NCT01366339 is a clinical study titled "Tolerance and Pharmacokinetics Study of MNTX Tablets". This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an...
What is the current status of trial NCT01366339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2003-10. Estimated completion is 2003-12.
What conditions does trial NCT01366339 study?
This clinical trial studies the following conditions: Normal Healthy Volunteers.
What interventions are being tested in trial NCT01366339?
The interventions under investigation include: Oral placebo (DRUG), Oral methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01366339?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366339 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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