A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis

NCT07854249 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB161734-106
• 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 impaired renal function and participants on hemodialysis.

Conditions

Renal Insufficiency; Kidney Diseases

Keywords

renal impairment; hemodialysis; Kidney failure; end-stage renal disease

Outcome Measures

Primary Outcomes (3)

• PK for plasma INCB161734: Cmax

  Defined as the maximum plasma concentration.

  Up to approximately 3.5 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 3.5 months

• PK for plasma INCB161734: AUCinf

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

  Up to approximately 3.5 months

Secondary Outcomes (1)

• Number of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 3.5 months and 30 days

Study Arms (2)

Group 1: Severe renal impairment

EXPERIMENTAL

Participants with severe renal impairment will be enrolled in Group 1.

Drug: INCB161734

Group 2: End-stage renal disease (ESRD)

EXPERIMENTAL

Participants with end-stage renal disease will be enrolled in Group 2.

Drug: INCB161734

Interventions

INCB161734 DRUG

single dose administered orally

Group 1: Severe renal impairment; Group 2: End-stage renal disease (ESRD)

Eligibility Criteria

• Age: 18 Years - 85 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.
• Aged 18 to 85 years, inclusive, at the time of signing the ICF.
• Severe renal impairment or ESRD based on CKD-EPI (National Kidney Foundation).
• Participants with impaired renal function should have stable renal function (ie, those with acute changes in renal function should not be enrolled in the study).
• Medical findings consistent with the degree of renal dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
• BMI of 18.0 to 43.0 kg/m2 (inclusive) at screening.
• Ability to swallow and retain oral tablets.
• Willingness to avoid pregnancy, breastfeeding, or fathering children.

You may not qualify if:

• History of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, or neurological disease within 6 months before screening.
• History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including but not limited to the following:
• Recent myocardial infarction (within 6 months before check-in).
• New York Heart Association Class III or IV congestive heart failure.
• Unstable angina (within 6 months before check-in).
• Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).
• Uncontrolled hypertension.
• Participants who have a current, functioning organ transplant or are 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 cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg at screening, confirmed by repeat testing).
• Participants who have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
• Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
• History of malignancy within 5 years before screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
• Current or recent (within 3 months before screening) clinically significant GI disease or surgery (including cholecystectomy \[\< 2 months\]; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
• Confirmed resting pulse rate (up to 2 consecutive measurements) \< 40 bpm or \> 100 bpm at screening.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share