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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Incyte Corporation
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the PR Interval (PR)
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment Group 1
Povorcitinib and placebo will be administered at the protocol defined doses.
Intervention: Povorcitinib (Drug)
Treatment Group 1
Povorcitinib and placebo will be administered at the protocol defined doses.
Intervention: Placebo (Drug)
Treatment Group 2
Povorcitinib will be administered at the protocol defined doses.
Intervention: Povorcitinib (Drug)
Treatment Group 3
Placebo will be administered at the protocol defined doses.
Intervention: Placebo (Drug)
Treatment Group 4
Moxifloxacin will be administered at the protocol defined doses.
Intervention: Moxifloxacin (Drug)
Outcomes
Primary Outcomes
Change from Baseline in the PR Interval (PR)
Time Frame: Up to Day 3
Electrocardiogram measurement of change from baseline in PR.
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)
Change from Baseline in heart rate (HR)
Time Frame: Up to Day 3
Electrocardiogram measurement of change from baseline in HR.
Change from Baseline in the QRS interval (QRS)
Time Frame: Up to Day 3
Electrocardiogram measurement of change from baseline in QRS.
Secondary Outcomes
- Povorcitinib concentration in plasma(Up to Day 7)
- Moxifloxacin concentration in plasma(Up to Day 7)
- Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs)(Up to Day 22)