Healthy ParticipantsPhase 1NCT06775327
Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants
A Phase 1 study testing INCB000631 in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB000631
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 28 May 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 19 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 19 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a body mass index > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory [except lipids], and ECG) as determined by the investigator. If the investigator has questions about clinically significant findings, the medical monitor should be consulted.
- Ability to swallow and retain oral tablets.
- Willingness to avoid pregnancy or fathering children based on the protocol defined criteria.
Who cannot join
- History of uncontrolled or unstable respiratory, renal, gastrointestinal, endocrine, pulmonary, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of an autoimmune disease (eg, myasthenia gravis).
- History of cardiovascular, cerebrovascular, cerebral, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- High blood pressure (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg at screening, confirmed by repeat testing).
- Confirmed resting pulse (up to 3 measurements) < 40 bpm or > 100 bpm at screening for vital signs.
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. Participants with a QTcF interval > 450 milliseconds (males) or > 470 milliseconds (females), QRS interval > 120 milliseconds, or PR interval > 220 milliseconds will be excluded.
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- In the event a value is exclusionary, a single ECG will be repeated twice, and an average of the 3 readings will be used to determine if a participant should be excluded.
- Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
- History of other malignancy within 2 years of screening (with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy) or cancers from which the participant has been disease-free for < 1 year after treatment with curative intent.
- Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
- Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than the laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing, that is considered clinically significant in the opinion of the investigator to be exclusionary.
- Hepatic transaminases (ALT and AST), ALP, or total bilirubin > 1.25 × the laboratory-defined ULN at screening or at check-in, confirmed by repeat testing (except participants with Gilbert disease, for whom total bilirubin must be ≤ 2.0 × ULN).
- Any major surgery within 4 weeks of screening.
- 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).
- Blood transfusion within 4 months of check-in (Day -1).
- Chronic, known, or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent tuberculosis).
- 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.
- Received a live vaccine (including attenuated) within 3 months of the planned start of the study drug or anticipation of need for such a vaccine during the study. This includes seasonal influenza vaccines.
- Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid.
- History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = one-half pint of beer or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine).
- 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.
- Ingestion of caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, energy drinks, and chocolate) within 48 hours before check-in.
- Consumption of alcoholic beverages, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 48 hours before check-in.
- History of tobacco or nicotine-containing product use within 1 month of screening.
- 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 study.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Certara Drug Interaction Database for prohibited drugs).
- Current use of prohibited medication as described in the protocol.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB000631 or any excipients of INCB000631 or any SPPL2a inhibitors (refer to the IB).
- Inability to undergo venipuncture or tolerate venous access (participant has inadequate veins for repeat venipuncture or venous access as determined by the investigator or designee).
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator or designee.
- Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including minerals and phytotherapeutics/herbals [including St John's wort]/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen and standard-dose vitamins are permitted. Mega-dose vitamins or supplements are not permissible.
- Pregnant or breastfeeding.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- eGFR < 90 mL/min/1.73 m2 based on the site's standard formula at screening. Note: Assessment of eGFR may be repeated once if outside of the reference range.
- Excessive exercise beyond the activities of daily living (eg, triathlon) within 7 days before check-in (Day -1).
- History of severe lactose intolerance or food allergies/intolerance to the composition of the standard high-fat breakfast to be served (Cohort G only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose Escalation, and Food-Effect Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants
This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.
- Conditions
- Healthy Participants
- Being tested
- INCB000631, Placebo
- Keywords
- INCB000631
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB000631Drug
Oral; Tablet
PlaceboDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Cohort B | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Cohort C | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Cohort D | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Cohort E | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Optional Cohort F | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. Receives: Drug: INCB000631; Drug: Placebo |
| Cohort G Treatment A | Experimental | INCB000631 will be administered at the protocol defined dose. Receives: Drug: INCB000631 |
| Cohort G Treatment B | Experimental | INCB000631 will be administered at the protocol defined dose. Receives: Drug: INCB000631 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after dose of study treatment.
Measured: Up to Day 41
PK for plasma INCB000631: Cmax
Maximum Observed Plasma Concentration of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: tmax
Time to maximum plasma concentration of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: AUC(0-t)
Area under the single-dose plasma concentration-time curve up to the last measurable plasma concentration of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: AUC 0-∞
Area under the single-dose plasma concentration-time curve from 0 to Infinity of INCB000631.
Measured: Up to Day 14
Secondary outcomes (7)
PK for plasma INCB000631: t1/2
Apparent terminal phase disposition half-life of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: CL/F
Dose clearance of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: Vz/F
Apparent oral dose volume of distribution of INCB000631.
Measured: Up to Day 14
PK for plasma INCB000631: λz
Apparent terminal-phase disposition rate constant of INCB000631.
Measured: Up to Day 14
PK for urine INCB000631: Ae96h
Amount of INCB000631 excreted in the urine over 96 hours.
Measured: Up to Day 14
PK for urine INCB000631: fe
Percent of INCB000631 excreted in the urine.
Measured: Up to Day 14
PK for urine INCB000631: CLR
Renal clearance of INCB000631.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start13 Feb 2025
- Primary completion28 May 2025
- Study completion28 May 2025
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
- 71 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
- NCT06775327
- Sponsor's protocol ID
- INCB000631-101
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2025
- Last updated
- 11 Jun 2025
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose Escalation, and Food-Effect Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06775327
- Acronym / sponsor ID
- INCB000631-101
- Conditions
- Healthy Participants
- Keywords
- INCB000631
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 15 Jan 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.
This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort B | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort C | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort D | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort E | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Optional Cohort F | Experimental | Drug: INCB000631, Drug: PlaceboINCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort G Treatment A | Experimental | Drug: INCB000631INCB000631 will be administered at the protocol defined dose. |
| Cohort G Treatment B | Experimental | Drug: INCB000631INCB000631 will be administered at the protocol defined dose. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 19 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a body mass index > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory [except lipids], and ECG) as determined by the investigator. If the investigator has questions about clinically significant findings, the medical monitor should be consulted.
- Ability to swallow and retain oral tablets.
Key exclusion criteria (38 listed)
- History of uncontrolled or unstable respiratory, renal, gastrointestinal, endocrine, pulmonary, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of an autoimmune disease (eg, myasthenia gravis).
- History of cardiovascular, cerebrovascular, cerebral, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- High blood pressure (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg at screening, confirmed by repeat testing).
- Confirmed resting pulse (up to 3 measurements) < 40 bpm or > 100 bpm at screening for vital signs.
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 |
|---|---|---|
| INCB000631Oral; Tablet | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort G Treatment A, Cohort G Treatment B, Optional Cohort F |
| PlaceboOral; Tablet | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Optional Cohort F |
Primary outcome
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 41
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after dose of study treatment.
PK for plasma INCB000631: Cmax
Time frame: Up to Day 14
Maximum Observed Plasma Concentration of INCB000631.
PK for plasma INCB000631: tmax
Time frame: Up to Day 14
Time to maximum plasma concentration of INCB000631.
PK for plasma INCB000631: AUC(0-t)
Time frame: Up to Day 14
Area under the single-dose plasma concentration-time curve up to the last measurable plasma concentration of INCB000631.
PK for plasma INCB000631: AUC 0-∞
Time frame: Up to Day 14
Area under the single-dose plasma concentration-time curve from 0 to Infinity of INCB000631.
7 secondary outcomes
PK for plasma INCB000631: t1/2
Time frame: Up to Day 14
PK for plasma INCB000631: CL/F
Time frame: Up to Day 14
PK for plasma INCB000631: Vz/F
Time frame: Up to Day 14
PK for plasma INCB000631: λz
Time frame: Up to Day 14
PK for urine INCB000631: Ae96h
Time frame: Up to Day 14
PK for urine INCB000631: fe
Time frame: Up to Day 14
PK for urine INCB000631: CLR
Time frame: Up to Day 14
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.
- Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, \& Food Effect of Oral INCB000631 to Healthy Adult ParticipantsLink provided by the sponsor.
- 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 INCB000631 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 6 inclusion and 38 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?
Number of participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 41). The study lists 5 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.