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

NCT05467709 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Health Volunteers

Keywords

CTP-543

Outcome Measures

Primary Outcomes (8)

• Cmax

  Maximum observed concentration

  Day 14, 15, 16, Discharge (Day 17)

• Tmax

  Time to reach maximum observed concentration

  Day 14, 15, 16, Discharge (Day 17)

• AUC0-inf

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

  Day 14, 15, 16, Discharge (Day 17)

• AUC0-t

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

  Day 14, 15, 16, Discharge (Day 17)

• λz

  Terminal elimination rate constant

  Day 14, 15, 16, Discharge (Day 17)

• t1/2

  Apparent terminal half-life

  Day 14, 15, 16, Discharge (Day 17)

• CL/F

  Apparent total plasma clearance (Midazolam only)

  Day 1, 2, 16, Discharge (Day 17)

• Vz/F

  Apparent volume of distribution (Midazolam only)

  Day 1, 2, 16, Discharge (Day 17)

Secondary Outcomes (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)

Study Arms (1)

CTP-543

EXPERIMENTAL

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; Drug: CTP-543

Interventions

Midazolam DRUG

2 mg Day 1 and Day 16

CTP-543

CTP-543 DRUG

12 mg q12 hour for 14 consecutive days starting on Day 3

CTP-543

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 20, 2022
• Study Start: June 21, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 7, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

US (1)