Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05467709
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Days): 16
• Patients Per Site Per Month: 38

Study Details

Study Description

Brief Summary

This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects

Condition or Disease	Intervention/Treatment	Phase
Health Volunteers	Drug: Midazolam; Drug: CTP-543	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
• Actual Study Start Date: Jun 21, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jul 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-543 Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16.	Drug: Midazolam; 2 mg Day 1 and Day 16; Drug: CTP-543; 12 mg q12 hour for 14 consecutive days starting on Day 3

Outcome Measures

Primary Outcome Measures

1. Cmax [Day 14, 15, 16, Discharge (Day 17)]

   Maximum observed concentration

2. Tmax [Day 14, 15, 16, Discharge (Day 17)]

   Time to reach maximum observed concentration

3. AUC0-inf [Day 14, 15, 16, Discharge (Day 17)]

   Area under the concentration-time curve from time 0 extrapolated to infinity

4. AUC0-t [Day 14, 15, 16, Discharge (Day 17)]

   Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration

5. λz [Day 14, 15, 16, Discharge (Day 17)]

   Terminal elimination rate constant

6. t1/2 [Day 14, 15, 16, Discharge (Day 17)]

   Apparent terminal half-life

7. CL/F [Day 1, 2, 16, Discharge (Day 17)]

   Apparent total plasma clearance (Midazolam only)

8. Vz/F [Day 1, 2, 16, Discharge (Day 17)]

   Apparent volume of distribution (Midazolam only)

Secondary Outcome Measures

1. Assessment of Safety and Tolerability following administration of CTP-543 [Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)]

   Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Healthy, adult, male or female, aged 18-60

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

• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening

• If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication

• Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

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

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

• Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects

• History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF)

450 msec for males or QTcF > 470 msec for females at screening visit or prior to the first dosing

• Abnormal liver function at screening

• 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 for coronavirus infection (COVID-19) at screening or check-in

• Positive drug or alcohol results at screening or check-in

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

• Participation in another clinical study within 30 days prior to, and 30 days after the first dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami, LLC	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: NCT05467709
• Other Study ID Numbers: CP543.1012
• First Posted: Jul 20, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Concert Pharmaceuticals: CTP-543
• Additional relevant MeSH terms: Midazolam

Study Results

No Results Posted as of Jul 20, 2022