Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inducer, Rifampin, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843540
• Other study ID #: CP543.1008
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: July 2021
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study

• Body mass index (BMI) = 18.0 and = 32.0 kg/m2 at Screening

• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs

• If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication

• Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

• History or presence of clinically significant medical or psychiatric condition or disease

• History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study

• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing

• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug

• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)

• A positive test or history of incompletely treated or untreated tuberculosis

• Donation of > 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CTP-543
Rifampin as oral capsule

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Area Under the Plasma Concentration-Time Profile	16 hours
Primary	AUC0-inf	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time	16 hours
Primary	Cmax	Maximum observed concentration of drug in plasma	16 hours
Primary	Tmax	Time to reach maximum observed concentration of drug in plasma	16 hours
Secondary	Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention	Up to 47 days