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NCT01754818 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)
A Phase 1 study of Healthy, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01754818: Completed Phase 1 study of Healthy, sponsored by Stealth BioTherapeutics.
NCT01754818 is a Phase 1 study of Healthy that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy 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
NCT01754818, a Phase 1 study of Healthy, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.
Primary Outcome
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Mean Cmax is defined as the mean of maximum concentration reported for each subject by cohort.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bendavia 10mg
- DRUG Bendavia 50mg
- DRUG Bendavia 100mg
Study Locations (1)
Florida
- Clinical Pharmacology of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT01754818 record still lists
NCT01754818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01754818 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01754818 about?
NCT01754818 is a clinical study titled "A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)". The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.
What is the current status of trial NCT01754818?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2013-02.
What conditions does trial NCT01754818 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01754818?
The interventions under investigation include: Placebo (DRUG), Bendavia 10mg (DRUG), Bendavia 50mg (DRUG), Bendavia 100mg (DRUG).
Who is sponsoring clinical trial NCT01754818?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01754818 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT01754818's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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