A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment

NCT07853040 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB161734-105
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.

Conditions

Hepatic Insufficiency; Liver Diseases

Keywords

hepatic impairment; liver impairment (moderate and severe)

Outcome Measures

Primary Outcomes (3)

• PK for plasma INCB161734: Cmax

  Defined as the maximum plasma concentration.

  Up to approximately 1.5 months

• PK for plasma INCB161734: AUClast

  Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.

  Up to approximately 1.5 months

• PK for plasma INCB161734: AUCinf

  Defined as the area under concentration-time curve from time zero extrapolated to infinity.

  Up to approximately 1.5 months

Secondary Outcomes (7)

• Number of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 1.5 months and 15 days

• PK for plasma INCB161734: Tmax

  Up to approximately 1.5 months

• PK for plasma INCB161734: t½

  Up to approximately 1.5 months

• PK for plasma INCB161734: Tlast

  Up to approximately 1.5 months

• PK for plasma INCB161734: CL/F

  Up to approximately 1.5 months

Study Arms (2)

Cohort 1: Moderate hepatic impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will be enrolled in Cohort 1.

Drug: INCB161734

Cohort 2: Severe hepatic impairment

EXPERIMENTAL

Participants with severe hepatic impairment will be enrolled in Cohort 2.

Drug: INCB161734

Interventions

INCB161734 DRUG

single dose administered orally

Cohort 1: Moderate hepatic impairment; Cohort 2: Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to comprehend and willingness to sign a written ICF for the study.
• Age 18 to 80 years (inclusive) at the time of signing the ICF.
• Moderate or severe hepatic impairment based on Child-Pugh score.
• Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory examinations at screening and check-in.
• BMI of 18.0 to 44.0 kg/m2 (inclusive) at screening.
• Ability to swallow and retain oral tablets.
• Willingness to avoid pregnancy or fathering children.

You may not qualify if:

• In the opinion of the investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening or evidence of rapidly deteriorating hepatic function.
• History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
• Current, functioning organ transplant or on the national transplant list and expected to receive a transplant within 3 months.
• History of an autoimmune disease diagnosis (eg, myasthenia gravis).
• History of malignancy within 5 years before screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
• History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
• Severe ascites (ascites requiring paracentesis more than twice every 4 weeks) or encephalopathy ≥ Grade 2 (precludes them from understanding and signing an ICF).
• Any major surgery within 4 weeks before screening.
• Donation of blood within 4 weeks before screening (within 2 weeks for plasma only).
• Blood transfusion within 4 weeks before check-in (Day -1).
• Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in (Day -1).
• History of alcoholism within 3 months before screening.
• Positive breath, urine, or blood test for ethanol or positive serum or urine screen for drugs of abuse that is not otherwise explained by permitted concomitant medications.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before study drug administration with another investigational medication or current enrollment in another investigational drug study.
• Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before study drug administration with an inducer or inhibitor of CYP3A4, P-gp, or BCRP.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Hepatic Insufficiency; Liver Diseases; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share