Health Volunteers
Conditions
Keywords
CTP-543
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
Interventions
DRUGMidazolam
2 mg Day 1 and Day 16
DRUGCTP-543
12 mg q12 hour for 14 consecutive days starting on Day 3
Sponsors
Concert Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F | Day 1, 2, 16, Discharge (Day 17) | Apparent volume of distribution (Midazolam only) |
| Cmax | Day 14, 15, 16, Discharge (Day 17) | Maximum observed concentration |
| Tmax | Day 14, 15, 16, Discharge (Day 17) | Time to reach maximum observed concentration |
| AUC0-inf | Day 14, 15, 16, Discharge (Day 17) | Area under the concentration-time curve from time 0 extrapolated to infinity |
| 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 |
| λz | Day 14, 15, 16, Discharge (Day 17) | Terminal elimination rate constant |
| t1/2 | Day 14, 15, 16, Discharge (Day 17) | Apparent terminal half-life |
| CL/F | Day 1, 2, 16, Discharge (Day 17) | Apparent total plasma clearance (Midazolam only) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed