> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-effect-of-povorcitinib-on-the-qt-qtc-19281c8b-d3be-465d-9c77-166b877ae54d > Record changed: 2026-11-04 # A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants NCT06441318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Participants 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Start date 2024-07-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Title and summary **Summary** The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Short title** A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Dates **Completion date** 2024-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **First posted** 2024-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Registry last updated** 2024-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Primary completion date** 2024-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Start date** 2024-07-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Size and sites **Actual participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Identifiers **Registry ID** NCT06441318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **ClinicalTrials.gov ID** NCT06441318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Outcomes ### Primary outcomes 1. Change from Baseline in QT interval corrected using Fridericia's formula (QTcF) Timeframe: 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) Timeframe: Up to Day 3 Electrocardiogram measurement of change from baseline in HR. 3. Change from Baseline in the PR Interval (PR) Timeframe: Up to Day 3 Electrocardiogram measurement of change from baseline in PR. 4. Change from Baseline in the QRS interval (QRS) Timeframe: 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) Timeframe: 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 Timeframe: Up to Day 7 Povorcitinib concentration in plasma. 3. Moxifloxacin concentration in plasma Timeframe: Up to Day 7 Moxifloxacin concentration in plasma. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Sites - Celerion Clinical Research UnitTempe, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441318) ## Related records ### Drugs (2) - [Moxifloxacin](https://trialight.com/data/asset/moxifloxacin-17fc41bd-6b29-4dda-a755-554e6ce94ccc.md) - [Povorcitinib](https://trialight.com/data/asset/povorcitinib-e7c92ac5-b499-4404-a902-1fd2c87d8b9e.md) ### Lead sponsors (1) - [Incyte Corporation](https://trialight.com/data/company/incyte-corporation-e1151708-5233-40b6-a85b-04abb2816a9f.md) ### Targets (1) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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