Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CTP-543; Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

• Registration Number: NCT04309643
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-16
• Study Start: 2020-06-09
• Primary Completion: 2020-06-25
• Status Verified: 2020-07
• Study Completion: 2020-07-08
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol

• If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:

  1. Surgical sterilization of the partner (via vasectomy, hysterectomy, bilateral tubal ligation or bilateral salpingectomy) at least 4 months prior to first dose or post-menopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels (> 40 IU/L) consistent with postmenopausal status
  2. Sexual partner is sterile, or of the same sex
  3. Double-barrier method (any combination of physical and chemical methods)
  4. Non-hormone releasing intrauterine device in females

• Continuous 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

• Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs

• Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria

• Positive pregnancy test
• 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 pose 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
• A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• Donation of blood or significant blood loss within 56 days prior to dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CTP-543	Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)	In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4.
CTP-543	CTP-543	In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4.

Primary Outcome Measures

Name	Time	Method
AUC0-t	From the start of Period 1 to completion of Period 2 (16 days)	Area Under the Plasma Concentration-Time Profile
Cmax	From the start of Period 1 to completion of Period 2 (16 days)	Maximum observed concentration of drug in plasma
AUC0-inf	From the start of Period 1 to completion of Period 2 (16 days)	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to 58 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
Number of Participants With Clinically Significant Change in Vital Signs	Up to 44 days	Blood pressure, heart rate, respiratory rate, and temperature
Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations	Up to 44 days	Hematology, serum chemistry, coagulation, and urinalysis
Number of Participants With Clinically Significant Change in Electrocardiogram	Up to 40 days	12-Lead ECG
Number of Participants With Clinically Significant Change to the Physical Examination	Screening (Day -28)	Symptom-driven physical examinations may be performed at other times, if deemed necessary

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Tempe, Arizona, United States