Renal InsufficiencyPhase 1NCT07854249
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis
A Phase 1 study testing INCB161734 in people with Renal Insufficiency and Kidney Diseases, run by Incyte Corporation.
Trial summary
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with impaired renal function and participants on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Insufficiency, Kidney Diseases
- What is being tested?
- INCB161734
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 30 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening.
- Any major surgery within 4 weeks before screening. Note: This does not include procedure for HD.
- Blood transfusion within 4 weeks before check-in (Day -1).
- Chronic or current active infectious disease (including latent tuberculosis) requiring systemic antibiotic, antifungal, or antiviral treatment.
- Positive test result for HBV, HCV, or HIV. Upon testing, HBV DNA and HCV RNA must be undetectable.
- Note 1: Participants with no prior history of HBV infection who have been vaccinated against HBV and who have a positive HBsAg antibody test as the only evidence of prior exposure may participate in the study.
- Note 2: Participants who have cleared a prior HBV infection (defined as HbsAg negative, HBsAb positive, or HBcAb positive) may be included at the discretion of the investigator.
- Receipt of any vaccine including but not limited to live (including attenuated), influenza, and SARS-CoV-2 vaccines within 3 months before the first dose of study drug.
- Medical or self-reported history of alcoholism within 3 years before screening.
- History of significant alcohol use, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females, within 3 months before screening.
- 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.
- Treatment within 14 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 Drug Interaction Database Program for prohibited drugs).
- Active infection requiring systemic therapy.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB161734, any excipients of INCB161734, or any KRAS inhibitors (refer to the IB).
- Inability to undergo venipuncture or tolerate venous access, or inadequate veins for repeat venipuncture or venous access as determined by the investigator.
- Tobacco or nicotine-containing product use of > 10 cigarettes per day within 1 month before screening.
- Use of prescription drugs (including hormonal contraceptives) within 14 days before study drug administration or nonprescription medications/products (including megadose vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations as well as pre/probiotics) within 7 days of study drug administration
- Note 1: Occasional acetaminophen, standard-dose ibuprofen, and standard-dose vitamins are permitted.
- Note 2: Established therapy for renal disease, or the treatment of associated disorders, that has been stable for at least 7 days prior to study drug administration, is allowed if approved by the medical monitor and investigator.
- Participants who are pregnant or lactating.
- Excessive exercise (eg, Ironman, bi/triathlon) within 3 months before screening.
- Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.
- Participants who have a history of paracentesis within 3 months prior to check-in.
- Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.
- Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.
- Esophageal banding within 3 months prior to check-in or required any other treatment for GI bleeding within 6 months prior to check-in.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis
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
- Being tested
- INCB161734
- Keywords
- renal impairment, hemodialysis, Kidney failure, end-stage renal disease
- Medical subject headings
- Renal Insufficiency, Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
single dose administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Severe renal impairment | Experimental | Participants with severe renal impairment will be enrolled in Group 1. Receives: Drug: INCB161734 |
| Group 2: End-stage renal disease (ESRD) | Experimental | Participants with end-stage renal disease will be enrolled in Group 2. Receives: Drug: INCB161734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK for plasma INCB161734: Cmax
Defined as the maximum plasma concentration.
Measured: 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.
Measured: 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.
Measured: Up to approximately 3.5 months
Secondary outcomes (1)
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug.
Measured: Up to approximately 3.5 months and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07854249
- Sponsor's protocol ID
- INCB161734-106
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis
- ClinicalTrials.gov ID
- NCT07854249
- Acronym / sponsor ID
- INCB161734-106
- Conditions
- Renal Insufficiency, Kidney Diseases
- Keywords
- renal impairment, hemodialysis, Kidney failure, end-stage renal disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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 is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with impaired renal function and participants on hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Severe renal impairment | Experimental | Drug: INCB161734Participants with severe renal impairment will be enrolled in Group 1. |
| Group 2: End-stage renal disease (ESRD) | Experimental | Drug: INCB161734Participants with end-stage renal disease will be enrolled in Group 2. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- 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.
Key exclusion criteria (43 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, or neurological disease within 6 months before screening.
- 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.
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 |
|---|---|---|
| INCB161734single dose administered orally | Drug | Group 1: Severe renal impairment, Group 2: End-stage renal disease (ESRD) |
Primary outcome
PK for plasma INCB161734: Cmax
Time frame: Up to approximately 3.5 months
Defined as the maximum plasma concentration.
PK for plasma INCB161734: AUClast
Time frame: Up to approximately 3.5 months
Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.
PK for plasma INCB161734: AUCinf
Time frame: Up to approximately 3.5 months
Defined as the area under concentration-time curve from time zero extrapolated to infinity.
1 secondary outcome
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3.5 months and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
Incyte Medical Monitor study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB161734 in people with Renal Insufficiency and Kidney Diseases, run by Incyte Corporation.
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 8 inclusion and 43 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK for plasma INCB161734: Cmax (time frame: Up to approximately 3.5 months). The study lists 3 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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.