Healthy VolunteersPhase 1NCT06941077
A Study to Evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants
A Phase 1 study testing INCB057643 in people with Healthy Volunteers, run by Incyte Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally 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 Volunteers
- What is being tested?
- INCB057643
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 3 Jun 2025
- 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.
- Aged 18 to 55 years, inclusive, at the time of signing the ICF.
- BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
- Ability to swallow and retain oral medication.
Who cannot join
- History of uncontrolled or unstable respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- High blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
- History or presence of an abnormal ECG before screening and check-in that, in the investigator's opinion, is clinically significant, such as a QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, or PR interval > 220 milliseconds.
- History or presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- Hepatic transaminases (ALT and AST), ALP, or total bilirubin > 1.25 × the laboratory-defined ULN at screening and check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be ≤ 2.0 × ULN).
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- Any major surgery within 4 weeks of screening.
- Current or recent (within 3 months of screening) clinically significant GI disease or surgery (including cholecystectomy and excluding appendectomy) that could affect the absorption of study drug.
- Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only).
- 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 significant alcohol use, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = 8 ounces of beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
- Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug or investigational product study.
- History of tobacco or nicotine-containing product use within 1 month of screening.
- Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen and ibuprofen and standard-dose vitamins are permitted. Megadose vitamins or supplements are not permissible.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants
The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.
- Conditions
- Healthy Volunteers
- Being tested
- INCB057643
- Keywords
- INCB057643
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB057643Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose Treatment A | Experimental | INCB057643 will be administered at protocol defined dose. Receives: Drug: INCB057643 |
| Cohort 2: Dose Treatment B | Experimental | INCB057643 will be administered at protocol defined dose. Receives: Drug: INCB057643 |
| Cohort 3: Dose Treatment C | Experimental | INCB057643 will be administered at protocol defined dose. Receives: Drug: INCB057643 |
| Cohort 4: Dose Treatment D | Experimental | INCB057643 will be administered at protocol defined dose. Receives: Drug: INCB057643 |
| Cohort 4: Dose Treatment E | Experimental | INCB057643 will be administered at protocol defined dose. Receives: Drug: INCB057643 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter (PK): Cmax of INCB057643
Defined as maximum observed plasma concentration of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: AUC(0-last) of INCB057643
Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: AUC 0-∞ of INCB057643
Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.
Measured: Up to Day 10
Secondary outcomes (7)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to Day 26
Pharmacokinetics Parameter: Tmax of INCB057643
Defined as the time to reach the maximum plasma concentration of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: t1/2 of INCB057643
Defined as the apparent terminal phase disposition half-life of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: CL/F INCB057643
Defined as the apparent oral dose clearance of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: V2/F of INCB057643
Defined as the apparent oral dose volume of distribution of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: λz of INCB057643
Defined as apparent terminal-phase disposition rate constant of INCB057643.
Measured: Up to Day 10
Pharmacokinetics Parameter: %AUCexp of INCB057643
Defined as percentage of AUC0-∞ due to extrapolation from the time of last quantifiable concentration to infinity of INCB057643.
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 May 2025
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Model description
- Cohorts 1-3 are single dose, and Cohort 4 is single dose, 2-way crossover.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Study Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941077
- Sponsor's protocol ID
- INCB057643-111
- Status last verified
- Jun 2025
- First submitted
- 16 Apr 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants
- ClinicalTrials.gov ID
- NCT06941077
- Acronym / sponsor ID
- INCB057643-111
- Conditions
- Healthy Volunteers
- Keywords
- INCB057643
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 23 Apr 2025 (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 Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Cohorts 1-3 are single dose, and Cohort 4 is single dose, 2-way crossover.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose Treatment A | Experimental | Drug: INCB057643INCB057643 will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | Experimental | Drug: INCB057643INCB057643 will be administered at protocol defined dose. |
| Cohort 3: Dose Treatment C | Experimental | Drug: INCB057643INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment D | Experimental | Drug: INCB057643INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment E | Experimental | Drug: INCB057643INCB057643 will be administered at protocol defined dose. |
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.
- Aged 18 to 55 years, inclusive, at the time of signing the ICF.
- BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
- Ability to swallow and retain oral medication.
Key exclusion criteria (16 listed)
- History of uncontrolled or unstable respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- High blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
- History or presence of an abnormal ECG before screening and check-in that, in the investigator's opinion, is clinically significant, such as a QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, or PR interval > 220 milliseconds.
- History or presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
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 |
|---|---|---|
| INCB057643Tablet | Drug | Cohort 1: Dose Treatment A, Cohort 2: Dose Treatment B, Cohort 3: Dose Treatment C, Cohort 4: Dose Treatment D, Cohort 4: Dose Treatment E |
Primary outcome
Pharmacokinetics Parameter (PK): Cmax of INCB057643
Time frame: Up to Day 10
Defined as maximum observed plasma concentration of INCB057643.
Pharmacokinetics Parameter: AUC(0-last) of INCB057643
Time frame: Up to Day 10
Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.
Pharmacokinetics Parameter: AUC 0-∞ of INCB057643
Time frame: Up to Day 10
Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.
7 secondary outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 26
Pharmacokinetics Parameter: Tmax of INCB057643
Time frame: Up to Day 10
Pharmacokinetics Parameter: t1/2 of INCB057643
Time frame: Up to Day 10
Pharmacokinetics Parameter: CL/F INCB057643
Time frame: Up to Day 10
Pharmacokinetics Parameter: V2/F of INCB057643
Time frame: Up to Day 10
Pharmacokinetics Parameter: λz of INCB057643
Time frame: Up to Day 10
Pharmacokinetics Parameter: %AUCexp of INCB057643
Time frame: Up to Day 10
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 11 Jun 2025.
- A Study to Evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy ParticipantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Healthy Participants
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 Study 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 INCB057643 in people with Healthy Volunteers, 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 16 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 11 Jun 2025. 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. 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?
Pharmacokinetics Parameter (PK): Cmax of INCB057643 (time frame: Up to Day 10). The study lists 3 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 11 Jun 2025.