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NCT03187015 · ClinicalTrials.gov registry record · Phase 1
A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects
A Phase 1 study of Healthy Volunteer and Drug Interaction, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03187015: Completed Phase 1 study of Healthy Volunteer and Drug Interaction, sponsored by Syndax Pharmaceuticals.
NCT03187015 is a Phase 1 study of Healthy Volunteer and Drug Interaction that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 26 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187015, a Phase 1 study of Healthy Volunteer and Drug Interaction, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of Midazolam. The primary objective is to evaluate the effect of a single oral dose of entinostat on the pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects. The secondary objective is to evaluate the safety and tolerability of combined administration of entinostat and midazolam in healthy subjects.
Primary Outcome
AUC0-t for midazolam and 1 OH midazolam will be computed.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Entinostat
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2017-08-22 |
| Phase | Phase 1 |
What the finished NCT03187015 record still lists
NCT03187015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT03187015 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT03187015 about?
NCT03187015 is a clinical study titled "A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects". The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of Midazolam. The primary objective is to evaluate the effect of a single oral dose of entinostat on the pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects. The secondary objective is...
What is the current status of trial NCT03187015?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-05-23. Estimated completion is 2017-08-22.
What conditions does trial NCT03187015 study?
This clinical trial studies the following conditions: Healthy Volunteer, Drug Interaction.
What interventions are being tested in trial NCT03187015?
The interventions under investigation include: Midazolam (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03187015?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03187015 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03187015's enrollment target sits among peer trials
26 83rd of 112 higher than 30 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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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