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

Health Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467709
• Other study ID #: CP543.1012
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 7, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Volunteers

Intervention

Drug:
• Midazolam
2 mg Day 1 and Day 16
• CTP-543
12 mg q12 hour for 14 consecutive days starting on Day 3

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, LLC	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	Cmax	Maximum observed concentration	Day 14, 15, 16, Discharge (Day 17)
Primary	Tmax	Time to reach maximum observed concentration	Day 14, 15, 16, Discharge (Day 17)
Primary	AUC0-inf	Area under the concentration-time curve from time 0 extrapolated to infinity	Day 14, 15, 16, Discharge (Day 17)
Primary	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)
Primary	?z	Terminal elimination rate constant	Day 14, 15, 16, Discharge (Day 17)
Primary	t1/2	Apparent terminal half-life	Day 14, 15, 16, Discharge (Day 17)
Primary	CL/F	Apparent total plasma clearance (Midazolam only)	Day 1, 2, 16, Discharge (Day 17)
Primary	Vz/F	Apparent volume of distribution (Midazolam only)	Day 1, 2, 16, Discharge (Day 17)
Secondary	Assessment of Safety and Tolerability following administration of CTP-543	Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject	Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)