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

NCT06380205 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB54707-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

INCB054707

Outcome Measures

Primary Outcomes (2)

• Levonorgestrel (LNG) concentration in plasma

  LNG concentration in plasma.

  Up to Day 21

• Ethinyl estradiol (EE) concentration in plasma

  EE concentration in plasma.

  Up to Day 21

Secondary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Povorcitinib; Drug: Levonorgestrel/Ethinyl estradiol

Interventions

Povorcitinib DRUG

Povorcitinib will be administered at protocol defined dose.

Also known as: INCB054707

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

Levonorgestrel/Ethinyl estradiol DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion Clinical Research Unit

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 23, 2024
• Study Start: May 7, 2024
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)