Healthy ParticipantsPhase 1NCT06441318
A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants
A Phase 1 study testing Povorcitinib and Moxifloxacin in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Povorcitinib and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to 10 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Tempe, Arizona, 85253
About this study
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
The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Povorcitinib, Placebo, Moxifloxacin
- Keywords
- INCB054707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovorcitinibDrug
Also called INCB054707
Povorcitinib will be administered at protocol defined dose.
PlaceboDrug
Placebo will be administered at protocol defined dose.
MoxifloxacinDrug
Moxifloxacin will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Povorcitinib and placebo will be administered at the protocol defined doses. Receives: Drug: Povorcitinib; Drug: Placebo |
| Treatment Group 2 | Experimental | Povorcitinib will be administered at the protocol defined doses. Receives: Drug: Povorcitinib |
| Treatment Group 3 | Placebo comparator | Placebo will be administered at the protocol defined doses. Receives: Drug: Placebo |
| Treatment Group 4 | Active comparator | Moxifloxacin will be administered at the protocol defined doses. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to Day 3
Change from Baseline in heart rate (HR)
Electrocardiogram measurement of change from baseline in HR.
Measured: Up to Day 3
Change from Baseline in the PR Interval (PR)
Electrocardiogram measurement of change from baseline in PR.
Measured: Up to Day 3
Change from Baseline in the QRS interval (QRS)
Electrocardiogram measurement of change from baseline in QRS.
Measured: Up to Day 3
Secondary outcomes (3)
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.
Measured: Up to Day 22
Povorcitinib concentration in plasma
Povorcitinib concentration in plasma.
Measured: Up to Day 7
Moxifloxacin concentration in plasma
Moxifloxacin concentration in plasma.
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start12 Jul 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441318
- Sponsor's protocol ID
- INCB54707-107
- Status last verified
- Sep 2024
- First submitted
- 29 May 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06441318
- Acronym / sponsor ID
- INCB54707-107
- Conditions
- Healthy Participants
- Keywords
- INCB054707
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: Povorcitinib, Drug: PlaceboPovorcitinib and placebo will be administered at the protocol defined doses. |
| Treatment Group 2 | Experimental | Drug: PovorcitinibPovorcitinib will be administered at the protocol defined doses. |
| Treatment Group 3 | Placebo comparator | Drug: PlaceboPlacebo will be administered at the protocol defined doses. |
| Treatment Group 4 | Active comparator | Drug: MoxifloxacinMoxifloxacin will be administered at the protocol defined doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovorcitinibAlso: INCB054707Povorcitinib will be administered at protocol defined dose. | Drug | Treatment Group 1, Treatment Group 2 |
| PlaceboPlacebo will be administered at protocol defined dose. | Drug | Treatment Group 1, Treatment Group 3 |
| MoxifloxacinMoxifloxacin will be administered at protocol defined dose. | Drug | Treatment Group 4 |
Primary outcome
Change from Baseline in QT interval corrected using Fridericia's formula (QTcF)
Time frame: Up to Day 3
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
Change from Baseline in heart rate (HR)
Time frame: Up to Day 3
Electrocardiogram measurement of change from baseline in HR.
Change from Baseline in the PR Interval (PR)
Time frame: Up to Day 3
Electrocardiogram measurement of change from baseline in PR.
Change from Baseline in the QRS interval (QRS)
Time frame: Up to Day 3
Electrocardiogram measurement of change from baseline in QRS.
3 secondary outcomes
Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs)
Time frame: Up to Day 22
Povorcitinib concentration in plasma
Time frame: Up to Day 7
Moxifloxacin concentration in plasma
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povorcitinib and Moxifloxacin in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in QT interval corrected using Fridericia's formula (QTcF) (time frame: Up to Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.