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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 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.

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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.

Conditions Studied

Healthy Volunteers

Interventions

  • DRUG Rifampin
  • DRUG Fedratinib
  • DRUG Efavirenz

Study Locations (1)

Texas

  • Covance Clinical Research Unit Inc - Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2019-06-21
Est. Completion 2019-11-06
Phase Phase 1

Sponsor

Celgene

308 total trials

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What the Registry Record Tells You About NCT03983239

The ClinicalTrials.gov registry entry for NCT03983239 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.