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

NCT06441318 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB54707-107
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

INCB054707

Outcome Measures

Primary Outcomes (4)

• 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

• Change from Baseline in heart rate (HR)

  Electrocardiogram measurement of change from baseline in HR.

  Up to Day 3

• Change from Baseline in the PR Interval (PR)

  Electrocardiogram measurement of change from baseline in PR.

  Up to Day 3

• Change from Baseline in the QRS interval (QRS)

  Electrocardiogram measurement of change from baseline in QRS.

  Up to Day 3

Secondary Outcomes (3)

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

  Up to Day 22

• Povorcitinib concentration in plasma

  Up to Day 7

• Moxifloxacin concentration in plasma

  Up to Day 7

Study Arms (4)

Treatment Group 1

EXPERIMENTAL

Povorcitinib and placebo will be administered at the protocol defined doses.

Drug: Povorcitinib; Drug: Placebo

Treatment Group 2

EXPERIMENTAL

Povorcitinib will be administered at the protocol defined doses.

Drug: Povorcitinib

Treatment Group 3

PLACEBO COMPARATOR

Placebo will be administered at the protocol defined doses.

Drug: Placebo

Treatment Group 4

ACTIVE COMPARATOR

Moxifloxacin will be administered at the protocol defined doses.

Drug: Moxifloxacin

Interventions

Povorcitinib DRUG

Povorcitinib will be administered at protocol defined dose.

Also known as: INCB054707

Treatment Group 1; Treatment Group 2

Placebo DRUG

Placebo will be administered at protocol defined dose.

Treatment Group 1; Treatment Group 3

Moxifloxacin DRUG

Moxifloxacin will be administered at protocol defined dose.

Treatment Group 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion Clinical Research Unit

Tempe, Arizona, 85253, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 12, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)