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

NCT ID: NCT06380205

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2024-06-07

Brief Summary

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

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)

Povorcitinib and LNG/EE will be administered at the protocol defined doses.

Group Type: EXPERIMENTAL

Povorcitinib

Intervention Type: DRUG

Povorcitinib will be administered at protocol defined dose.

Levonorgestrel/Ethinyl estradiol

Intervention Type: DRUG

Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose.

Interventions

Povorcitinib

Povorcitinib will be administered at protocol defined dose.

Intervention Type: DRUG

Levonorgestrel/Ethinyl estradiol

Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose.

Intervention Type: DRUG

Other Intervention Names

INCB054707

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Celerion Clinical Research Unit

Tempe, Arizona, United States

Countries

United States

Other Identifiers

INCB54707-111

Identifier Type: -

Identifier Source: org_study_id