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

NCT ID: NCT04309643

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2020-07-08

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.

Conditions

Healthy Volunteers

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CTP-543

Intervention Type: DRUG

Investigational Drug

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

Intervention Type: DRUG

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

Interventions

CTP-543

Investigational Drug

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celerion

INDUSTRY

Sponsor Role: collaborator

Concert Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion, Inc.

Tempe, Arizona, United States

Countries

United States

Other Identifiers

CP543.1005

Identifier Type: -

Identifier Source: org_study_id