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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Povorcitinib; Drug: Levonorgestrel/Ethinyl estradiol

• Registration Number: NCT06380205
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Study Start: 2024-05-07
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)	Povorcitinib	Povorcitinib and LNG/EE will be administered at the protocol defined doses.
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)	Levonorgestrel/Ethinyl estradiol	Povorcitinib and LNG/EE will be administered at the protocol defined doses.

Primary Outcome Measures

Name	Time	Method
Levonorgestrel (LNG) concentration in plasma	Up to Day 21	LNG concentration in plasma.
Ethinyl estradiol (EE) concentration in plasma	Up to Day 21	EE concentration in plasma.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Up to Day 32	Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.
Additional LNG/EE PK parameters in plasma	Up to Day 21	Additional LNG/EE PK parameters in plasma.
Povorcitinib concentration in plasma	Up to Day 21	Povorcitinib concentration in plasma.

Trial Locations

Locations (1)

Celerion Clinical Research Unit; 🇺🇸 Tempe, Arizona, United States