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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06441318
• Other study ID #: INCB54707-107
• Status: Recruiting
• Phase: Phase 1
• Start date: July 12, 2024
• Est. completion date: September 8, 2024

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 8, 2024
• Est. primary completion date: September 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Povorcitinib
Povorcitinib will be administered at protocol defined dose.
• Placebo
Placebo will be administered at protocol defined dose.
• Moxifloxacin
Moxifloxacin will be administered at protocol defined dose.

Locations

Country	Name	City	State
United States	Celerion Clinical Research Unit	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in QT interval corrected using Fridericia's formula (QTcF)	Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)	Up to Day 3
Primary	Change from Baseline in heart rate (HR)	Electrocardiogram measurement of change from baseline in HR.	Up to Day 3
Primary	Change from Baseline in the PR Interval (PR)	Electrocardiogram measurement of change from baseline in PR.	Up to Day 3
Primary	Change from Baseline in the QRS interval (QRS)	Electrocardiogram measurement of change from baseline in QRS.	Up to Day 3
Secondary	Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs)	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.	Up to Day 22
Secondary	Povorcitinib concentration in plasma	Povorcitinib concentration in plasma.	Up to Day 7
Secondary	Moxifloxacin concentration in plasma	Moxifloxacin concentration in plasma.	Up to Day 7