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Completed

NCT Number: NCT06441318

A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants

The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion Clinical Research Unit

Tempe, Arizona, 85253, 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.
  • Age 18 to 55 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 on screening evaluations as determined by the investigator (clinical, laboratory, and ECG).
  • 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 of screening. Participants with any history of myasthenia gravis will be excluded.
  • Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
  • Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy and excluding appendectomy and hernia repair) that could affect the absorption of study drug or moxifloxacin.
  • History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg 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 or breastfeeding.

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

Placebo

Drug

Placebo will be administered at protocol defined dose.

moxifloxacin

Drug

Moxifloxacin will be administered at protocol defined dose.

Primary outcomes

  1. Change from Baseline in QT interval corrected using Fridericia's formula (QTcF)

    Time frame: Up to Day 3

    Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)

  2. Change from Baseline in heart rate (HR)

    Time frame: Up to Day 3

    Electrocardiogram measurement of change from baseline in HR.

  3. Change from Baseline in the PR Interval (PR)

    Time frame: Up to Day 3

    Electrocardiogram measurement of change from baseline in PR.

  4. Change from Baseline in the QRS interval (QRS)

    Time frame: Up to Day 3

    Electrocardiogram measurement of change from baseline in QRS.

Secondary outcomes

  1. Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs)

    Time frame: Up to Day 22

    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.

  2. Povorcitinib concentration in plasma

    Time frame: Up to Day 7

    Povorcitinib concentration in plasma.

  3. Moxifloxacin concentration in plasma

    Time frame: Up to Day 7

    Moxifloxacin concentration in plasma.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1, Randomized, Partially Double-Blind, Placebo- and Positive-Controlled, Parallel Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Sep 25, 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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