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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CTP-543
* Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral contraceptive, Drug-drug Interaction, CTP-543