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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID

NCT06441318

Run by

Incyte Corporation

People needed

128

Starts

2024-07-12

Expected to finish

2024-09-10

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Celerion Clinical Research Unit — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.