Clinical trial NCT04309643: Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Oral contraceptive
Drug-drug Interaction
CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-03-16
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: AUC0-t
timeFrame: From the start of Period 1 to completion of Period 2 (16 days)
measure: AUC0-inf
timeFrame: From the start of Period 1 to completion of Period 2 (16 days)
measure: Cmax
timeFrame: From the start of Period 1 to completion of Period 2 (16 days)
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 58 days
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Up to 44 days
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations
timeFrame: Up to 44 days
measure: Number of Participants With Clinically Significant Change to the Physical Examination
timeFrame: Screening (Day -28)
measure: Number of Participants With Clinically Significant Change in Electrocardiogram
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
References: