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Completed

NCT Number: NCT06380205

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Celerion Clinical Research Unit

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

Povorcitinib will be administered at protocol defined dose.

Other names: INCB054707

Levonorgestrel/Ethinyl estradiol

Drug

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

Primary outcomes

  1. Levonorgestrel (LNG) concentration in plasma

    Time frame: Up to Day 21

    LNG concentration in plasma.

  2. Ethinyl estradiol (EE) concentration in plasma

    Time frame: Up to Day 21

    EE concentration in plasma.

Secondary outcomes

  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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.

  2. Additional LNG/EE PK parameters in plasma

    Time frame: Up to Day 21

    Additional LNG/EE PK parameters in plasma.

  3. Povorcitinib concentration in plasma

    Time frame: Up to Day 21

    Povorcitinib concentration in plasma.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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