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

NCT04743414 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Itraconazole; Drug-drug interaction; CTP-543

Outcome Measures

Primary Outcomes (4)

• AUC0-t

  Area Under the Plasma Concentration-Time Profile

  48 hours

• AUC0-inf

  Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time

  48 hours

• Cmax

  Maximum observed concentration of drug in plasma

  48 hours

• Tmax

  Time to reach maximum observed concentration of drug in plasma

  48 hours

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  Up to 40 days

Study Arms (1)

CTP-543

EXPERIMENTAL

On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7.

Drug: CTP-543

Interventions

CTP-543 DRUG

Itraconazole in solution dosage form

CTP-543

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: March 2, 2021
• Primary Completion: March 27, 2021
• Study Completion: April 5, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)