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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2024-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects

NCT05293171

Healthy Subjects

COMPLETED PHASE1

Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

NCT03808298

Healthy Volunteers

COMPLETED PHASE1

Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects

NCT02183467

Healthy

COMPLETED PHASE1

A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities

NCT06107036

Healthy

COMPLETED PHASE1

Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects

NCT02182310

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group 1

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

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Povorcitinib will be administered at protocol defined dose.

Placebo

Intervention Type DRUG

Placebo will be administered at protocol defined dose.

Treatment Group 2

Povorcitinib will be administered at the protocol defined doses.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Povorcitinib will be administered at protocol defined dose.

Treatment Group 3

Placebo will be administered at the protocol defined doses.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered at protocol defined dose.

Treatment Group 4

Moxifloxacin will be administered at the protocol defined doses.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin will be administered at protocol defined dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Povorcitinib

Povorcitinib will be administered at protocol defined dose.

Intervention Type DRUG

Placebo

Placebo will be administered at protocol defined dose.

Intervention Type DRUG

Moxifloxacin

Moxifloxacin will be administered at protocol defined dose.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INCB054707

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes