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Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

NCT03983239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-08-21

No results posted yet for this 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

  • Healthy Volunteers

Interventions

DRUG

Fedratinib

Fedratinib

DRUG

Rifampin

Rifampin

DRUG

Efavirenz

Efavirenz

Sponsors & Collaborators

  • Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

    collaborator INDUSTRY

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Leon Carayannopoulos, MD · Celgene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2019-11-02
Completion
2019-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983239 on ClinicalTrials.gov