Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03983239|
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : August 21, 2020
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:
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Fedratinib Drug: Rifampin Drug: Efavirenz||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, 2-part Study to Evaluate the Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects|
|Actual Study Start Date :||June 21, 2019|
|Actual Primary Completion Date :||November 2, 2019|
|Actual Study Completion Date :||November 6, 2019|
Experimental: Fedratinib plus Rifampin
A single dose of fedratinib on Day 1. On Days 9 through 18, once-daily (QD) doses of rifampin. On Day 17, a single dose of fedratinib will be concomitantly administered with rifampin.
Experimental: Fedratinib plus Efavirenz
A single dose of fedratinib on Day 1. On Days 9 through 18, once-daily (QD) doses of efavirenz. On Day 17, a single dose of fedratinib will be concomitantly administered with efavirenz.
- Fedratinib Pharmacokinetic - Cmax [ Time Frame: Up to approximately 8 days. ]Maximum observed plasma concentration
- Fedratinib Pharmacokinetic - Tmax [ Time Frame: Up to approximately 8 days. ]Time to maximum observed plasma concentration
- Fedratinib Pharmacokinetic - AUC0-t [ Time Frame: Up to approximately 8 days. ]Area under the curve from time zero to the last quantifiable concentration
- Fedratinib Pharmacokinetic - AUC0-∞ [ Time Frame: Up to approximately 8 days. ]Area under the curve from time zero extrapolated to infinity
- Fedratinib Pharmacokinetic - t1/2 [ Time Frame: Up to approximately 8 days. ]Terminal elimination half-life
- Fedratinib Pharmacokinetic - CL/F [ Time Frame: Up to approximately 8 days. ]Apparent total plasma clearance when dosed orally
- Fedratinib Pharmacokinetic - Vz/F [ Time Frame: Up to approximately 8 days. ]Apparent total volume of distribution when dosed orally
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 30 days after completion of study treatment ]Number of participants with an adverse event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983239
|United States, Texas|
|Covance Clinical Research Unit Inc - Dallas|
|Dallas, Texas, United States, 75247|
|Study Director:||Leon Carayannopoulos, MD||Celgene|