Healthy Volunteers
Conditions
Keywords
Oral contraceptive, Drug-drug Interaction, CTP-543
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.
Interventions
DRUGCTP-543
Investigational Drug
DRUGCombined 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)
Sponsors
Celerion
Concert Pharmaceuticals
Study design
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | From the start of Period 1 to completion of Period 2 (16 days) | Area Under the Plasma Concentration-Time Profile |
| AUC0-inf | From the start of Period 1 to completion of Period 2 (16 days) | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time |
| Cmax | From the start of Period 1 to completion of Period 2 (16 days) | Maximum observed concentration of drug in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change to the Physical Examination | Screening (Day -28) | Symptom-driven physical examinations may be performed at other times, if deemed necessary |
| Number of Participants with Adverse Events (AEs) | Up to 58 days | 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 |
| Number of Participants With Clinically Significant Change in Electrocardiogram | Up to 40 days | 12-Lead ECG |
| Number of Participants With Clinically Significant Change in Vital Signs | Up to 44 days | Blood pressure, heart rate, respiratory rate, and temperature |
| Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations | Up to 44 days | Hematology, serum chemistry, coagulation, and urinalysis |
Countries
United States
Outcome results
None listed