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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CTP-543; Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals
• Collaborators: Celerion

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Oral contraceptive; CTP-543; Drug-drug Interaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral; Contraceptives, Oral, Combined
• Other Study ID Numbers: CP543.1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No