Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB000631 When Administered Orally to Healthy Adult Participants

NCT07039929 | Terminated Phase 1 FDA Drug

• 1 other identifier: INCB000631-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to assess the safety, tolerability, and pharmacokinetics of INCB000631 when administered orally to healthy adult participants.

Conditions

Healthy Participants

Keywords

INCB000631

Outcome Measures

Primary Outcomes (9)

• 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 drug.

  Up to 2.5 months

• PK for plasma INCB000631: Cmax

  Maximum Observed Plasma Concentration of INCB000631.

  Up to Day 18

• PK for plasma INCB000631: tmax

  Time to maximum plasma concentration of INCB000631.

  Up to Day 18

• PK for plasma INCB000631: AUC(0-12)

  Area under the plasma concentration-time curve from Hour 0 to 12.

  Up to Day 18

• PK for plasma INCB000631: AUC(0-24)

  Area under the plasma concentration-time curve from Hour 0 to 24.

  Up to Day 18

• PK for plasma INCB000631: Ctrough

  Observed plasma concentration before the next dose of INCB000631.

  Up to Day 18

• PK for plasma INCB000631: AUCτ

  Area under the plasma concentration-time curve during the dosing period "τ".

  Up to Day 18

• PK for plasma INCB000631: AUC∞

  Area under the plasma concentration-time curve from time t to infinity.

  Up to Day 18

• PK for plasma INCB000631: AUClast

  Area under the plasma concentration-time curve to the last time point.

  Up to Day 18

Secondary Outcomes (9)

• PK for plasma INCB000631: t1/2

  Up to Day 18

• PK for plasma INCB000631: CL/F

  Up to Day 18

• PK for plasma INCB000631: Vz/F

  Up to Day 18

• PK for plasma INCB000631: λz

  Up to Day 18

• PK for urine INCB000631: Ae

  Up to Day 18

Study Arms (6)

Cohort A

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Cohort B

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Cohort C Treatment A

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Cohort C Treatment B

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Cohort D Treatment A

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Cohort D Treatment B

EXPERIMENTAL

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Drug: INCB000631; Drug: Placebo

Interventions

INCB000631 DRUG

Oral; Tablet

Cohort A; Cohort B; Cohort C Treatment A; Cohort C Treatment B; Cohort D Treatment A; Cohort D Treatment B

Placebo DRUG

Oral; Tablet

Cohort A; Cohort B; Cohort C Treatment A; Cohort C Treatment B; Cohort D Treatment A; Cohort D Treatment B

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.
• Age 19 to 55 years (in compliance with Nebraska state law), inclusive, at the time of signing the ICF.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
• No clinically significant findings on screening evaluations (clinical, laboratory \[except lipids\], and ECG).
• Ability to swallow and retain oral tablets.
• Willingness to avoid pregnancy or fathering children based on the criteria below.
• Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children, including refraining from donating sperm, from screening through 90 days (a spermatogenesis cycle) after the last dose of study drug. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
• All female participants must have a negative pregnancy test at screening and a negative pregnancy test at check-in (Day -1) and must agree to take appropriate precautions to avoid pregnancy and refrain from donating oocytes from screening through 30 days (1 menstrual cycle) after the last dose of study drug. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
• Female participants not considered to be of childbearing potential as defined in the protocol are eligible and must have a negative pregnancy test at screening and check-in.

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.
• 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 (up to twice).
• Hepatic transaminases (ALT and AST), ALP, or total bilirubin \> 1.25 × the laboratory-defined 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).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB000631 When Administered Orally 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

Model Details: Cohorts C and D will be dosed either once daily (Treatment A) or twice daily (Treatment B) not both.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: July 28, 2025
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)