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

NCT04309643 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Oral contraceptive; Drug-drug Interaction; CTP-543

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Participants with Adverse Events (AEs)

  Up to 58 days

• Number of Participants With Clinically Significant Change in Vital Signs

  Up to 44 days

• Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations

  Up to 44 days

• Number of Participants With Clinically Significant Change to the Physical Examination

  Screening (Day -28)

• Number of Participants With Clinically Significant Change in Electrocardiogram

  Up to 40 days

Study Arms (1)

CTP-543

EXPERIMENTAL

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

Interventions

CTP-543 DRUG

Investigational Drug

CTP-543

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

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

CTP-543

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concert Pharmaceuticals: lead
• Celerion: collaborator

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: June 9, 2020
• Primary Completion: June 25, 2020
• Study Completion: July 8, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)