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NCT03983239 · ClinicalTrials.gov registry record · Phase 1
Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03983239: Completed Phase 1 study of Healthy Volunteers, sponsored by Celgene.
NCT03983239 is a Phase 1 study of Healthy Volunteers that has completed, run by Celgene. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03983239, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order or in parallel. Subjects may participate in one part only. For each part, subjects will participate as follows: * Screening * Treatment period (includes baseline) * Follow-up telephone call (4 days \[± 2 days\] after discharge) During the study, blood samples will be collected at prespecified times for PK. Subject safety will be monitored throughout the study.
Primary Outcome
Maximum observed plasma concentration
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Fedratinib
- DRUG Efavirenz
Study Locations (1)
Texas
- Covance Clinical Research Unit Inc - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2019-11-06 |
| Phase | Phase 1 |
What the finished NCT03983239 record still lists
NCT03983239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Rifampin is the first listed.
NCT03983239 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03983239 about?
NCT03983239 is a clinical study titled "Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects". This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order ...
What is the current status of trial NCT03983239?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2019-06-21. Estimated completion is 2019-11-06.
What conditions does trial NCT03983239 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03983239?
The interventions under investigation include: Rifampin (DRUG), Fedratinib (DRUG), Efavirenz (DRUG).
Who is sponsoring clinical trial NCT03983239?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03983239 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
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 NCT03983239's enrollment target sits among peer trials
32 171st of 283 higher than 99 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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