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 Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
21
Investigational Drug
Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)
Celerion, Inc.
Tempe, Arizona, United States
AUC0-t
Area Under the Plasma Concentration-Time Profile
Time frame: 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
Time frame: From the start of Period 1 to completion of Period 2 (16 days)
Cmax
Maximum observed concentration of drug in plasma
Time frame: From the start of Period 1 to completion of Period 2 (16 days)
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
Time frame: Up to 58 days
Number of Participants With Clinically Significant Change in Vital Signs
Blood pressure, heart rate, respiratory rate, and temperature
Time frame: Up to 44 days
Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations
Hematology, serum chemistry, coagulation, and urinalysis
Time frame: 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
Time frame: Screening (Day -28)
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Number of Participants With Clinically Significant Change in Electrocardiogram
12-Lead ECG
Time frame: Up to 40 days