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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04743414
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 19.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CTP-543	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
• Actual Study Start Date: Mar 2, 2021
• Actual Primary Completion Date: Mar 27, 2021
• Actual Study Completion Date: Apr 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-543 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; Itraconazole in solution dosage form

Outcome Measures

Primary Outcome Measures

1. AUC0-t [48 hours]

   Area Under the Plasma Concentration-Time Profile

2. AUC0-inf [48 hours]

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

3. Cmax [48 hours]

   Maximum observed concentration of drug in plasma

4. Tmax [48 hours]

   Time to reach maximum observed concentration of drug in plasma

Secondary Outcome Measures

1. Number of Participants with Adverse Events (AEs) [Up to 40 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014

Sponsors and Collaborators

• Concert Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04743414
• Other Study ID Numbers: CP543.1007
• First Posted: Feb 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Concert Pharmaceuticals: Itraconazole; Drug-drug interaction; CTP-543

Study Results

No Results Posted as of Apr 8, 2021