A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females

Incyte

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Povorcitinib

Drug: Levonorgestrel/Ethinyl estradiol

Study type

Interventional

Funder types

Industry

Identifiers

NCT06380205

INCB54707-111

Details and patient eligibility

About

The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.

Enrollment

24 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Ability to comprehend and willingness to sign a written ICF for the study.
Females aged 18 to 60 years, inclusive, at the time of signing the ICF.
Body mass index between 18.0 and 30.5 kg/m2, inclusive.
No clinically significant findings in screening evaluations (eg, clinical, laboratory, and ECG evaluations).
Ability to swallow and retain oral medication.

Exclusion criteria

History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening.
Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.
Current or recent (within 3 months before screening) clinically significant gastrointestinal disease (eg, gallbladder disease) or surgery (including cholecystectomy; excluding appendectomy) that could affect the absorption of study treatment.
History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease (eg, deep vein thrombosis), pulmonary embolism, or uncontrolled hypertension (ie, blood pressure > 140/90 mmHg at screening, confirmed by repeat testing).
Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
History of tobacco- or nicotine-containing product-use within 1 month before screening.
Pregnant, breastfeeding, or planning to conceive during the study.

Other protocol-defined Inclusion/Exclusion Criteria may apply.