NCT06380205
Completed
Phase 1
A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
ConditionsHealthy Participants
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Incyte Corporation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Levonorgestrel (LNG) concentration in plasma
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)
Experimental
Povorcitinib and LNG/EE will be administered at the protocol defined doses.
Intervention: Povorcitinib (Drug)
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)
Experimental
Povorcitinib and LNG/EE will be administered at the protocol defined doses.
Intervention: Levonorgestrel/Ethinyl estradiol (Drug)
Outcomes
Primary Outcomes
Levonorgestrel (LNG) concentration in plasma
Time Frame: Up to Day 21
LNG concentration in plasma.
Ethinyl estradiol (EE) concentration in plasma
Time Frame: Up to Day 21
EE concentration in plasma.
Secondary Outcomes
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 32)
- Additional LNG/EE PK parameters in plasma(Up to Day 21)
- Povorcitinib concentration in plasma(Up to Day 21)
Investigators
Study Sites (1)
Loading locations...
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