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

Healthy Participants Clinical Trial

Official title:

A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06380205
• Other study ID #: INCB54707-111
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 7, 2024
• Est. completion date: June 7, 2024

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Povorcitinib
Povorcitinib will be administered at protocol defined dose.
• Levonorgestrel/Ethinyl estradiol
Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose.

Locations

Country	Name	City	State
United States	Celerion Clinical Research Unit	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levonorgestrel (LNG) concentration in plasma	LNG concentration in plasma.	Up to Day 21
Primary	Ethinyl estradiol (EE) concentration in plasma	EE concentration in plasma.	Up to Day 21
Secondary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to Day 32
Secondary	Additional LNG/EE PK parameters in plasma	Additional LNG/EE PK parameters in plasma.	Up to Day 21
Secondary	Povorcitinib concentration in plasma	Povorcitinib concentration in plasma.	Up to Day 21