CompletedPhase 1

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

United States48 participantsStarted 2021-12-14

Plain-language summary

This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.

Who can participate

Age range18 Years – 82 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Recent myocardial infarction (within 6 months of check-in).
✕. New York Heart Association Class III or IV congestive heart failure.
✕. Unstable angina (within 6 months of check-in).
✕. Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).
✕. Uncontrolled hypertension.

What they're measuring

PK for plasma of INCB000928: Cmax

Timeframe: Days 1 - 4

PK for plasma of INCB000928: AUC0-t

Timeframe: Days 1 - 4

PK for plasma of INCB000928: AUC0-∞

Timeframe: Days 1 - 4

Trial details

NCT IDNCT05099445

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-19

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