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NCT01367496 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
A Phase 1 study of Healthy Subjects, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01367496: Completed Phase 1 study of Healthy Subjects, sponsored by Bausch Health Americas.
NCT01367496 is a Phase 1 study of Healthy Subjects that has completed, run by Bausch Health Americas. The registered enrollment target is 6 participants, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367496, a Phase 1 study of Healthy Subjects, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.
Primary Outcome
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Conditions Studied
Interventions
- DRUG IV Methylnaltrexone (MNTX)
- DRUG SC Methylnaltrexone (MNTX)
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2002-06 |
| Est. Completion | 2002-08 |
| Phase | Phase 1 |
What the finished NCT01367496 record still lists
NCT01367496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 2 interventions - of which IV Methylnaltrexone (MNTX) is the first listed.
NCT01367496 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01367496 about?
NCT01367496 is a clinical study titled "Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose". This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality ...
What is the current status of trial NCT01367496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2002-06. Estimated completion is 2002-08.
What conditions does trial NCT01367496 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01367496?
The interventions under investigation include: IV Methylnaltrexone (MNTX) (DRUG), SC Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01367496?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01367496 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01367496's enrollment target sits among peer trials
6 68th of 69 the lowest of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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