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

Sponsor

Concert Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04309643

Collaborator

Celerion (Industry)

Enrollment

Location

Arm

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CTP-543 Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Phase 1, Open-label Study to Assess the Effect of CTP-543 on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects

Actual Study Start Date :

Jun 9, 2020

Actual Primary Completion Date :

Jun 25, 2020

Actual Study Completion Date :

Jul 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: CTP-543 Investigational Drug Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)

Arm

Intervention/Treatment

Experimental: 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.

Drug: CTP-543

Investigational Drug

Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)

Outcome Measures

Primary Outcome Measures

AUC0-t [From the start of Period 1 to completion of Period 2 (16 days)]
Area Under the Plasma Concentration-Time Profile
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
Cmax [From the start of Period 1 to completion of Period 2 (16 days)]
Maximum observed concentration of drug in plasma

Secondary Outcome Measures

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 to the Physical Examination [Screening (Day -28)]
Symptom-driven physical examinations may be performed at other times, if deemed necessary
Number of Participants With Clinically Significant Change in Electrocardiogram [Up to 40 days]
12-Lead ECG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

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
Sexual partner is sterile, or of the same sex
Double-barrier method (any combination of physical and chemical methods)
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