Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants

NCT06775327 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB000631-101
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

INCB000631

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to Day 41

• PK for plasma INCB000631: Cmax

  Maximum Observed Plasma Concentration of INCB000631.

  Up to Day 14

• PK for plasma INCB000631: tmax

  Time to maximum plasma concentration of INCB000631.

  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.

  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.

  Up to Day 14

Secondary Outcomes (7)

• PK for plasma INCB000631: t1/2

  Up to Day 14

• PK for plasma INCB000631: CL/F

  Up to Day 14

• PK for plasma INCB000631: Vz/F

  Up to Day 14

• PK for plasma INCB000631: λz

  Up to Day 14

• PK for urine INCB000631: Ae96h

  Up to Day 14

Study Arms (8)

Cohort A

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Cohort B

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Cohort C

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Cohort D

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Cohort E

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Optional Cohort F

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose.

Drug: INCB000631; Drug: Placebo

Cohort G Treatment A

EXPERIMENTAL

INCB000631 will be administered at the protocol defined dose.

Drug: INCB000631

Cohort G Treatment B

EXPERIMENTAL

INCB000631 will be administered at the protocol defined dose.

Drug: INCB000631

Interventions

INCB000631 DRUG

Oral; Tablet

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E; Cohort G Treatment A; Cohort G Treatment B; Optional Cohort F

Placebo DRUG

Oral; Tablet

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E; Optional Cohort F

Eligibility Criteria

• Age: 19 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, \& Food Effect of Oral INCB000631 to Healthy Adult Participants

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: January 9, 2025
• First Posted: January 15, 2025
• Study Start: February 13, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)