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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309643
• Other study ID #: CP543.1005
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2020
• Est. completion date: July 8, 2020

Study information

• Verified date: July 2020
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 8, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CTP-543
Investigational 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)

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Concert Pharmaceuticals	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Area Under the Plasma Concentration-Time Profile	From the start of Period 1 to completion of Period 2 (16 days)
Primary	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)
Primary	Cmax	Maximum observed concentration of drug in plasma	From the start of Period 1 to completion of Period 2 (16 days)
Secondary	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
Secondary	Number of Participants With Clinically Significant Change in Vital Signs	Blood pressure, heart rate, respiratory rate, and temperature	Up to 44 days
Secondary	Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations	Hematology, serum chemistry, coagulation, and urinalysis	Up to 44 days
Secondary	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)
Secondary	Number of Participants With Clinically Significant Change in Electrocardiogram	12-Lead ECG	Up to 40 days