A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIncyte Corporation
About this trial
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
INCB161734
Drugsingle dose administered orally
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Moderate hepatic impairmentExperimental treatment 1 intervention
Group B: Cohort 2: Severe hepatic impairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PK for plasma INCB161734: Cmax
Defined as the maximum plasma concentration.
Time frame
Up to approximately 1.5 months2
PK for plasma INCB161734: AUClast
Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.
Time frame
Up to approximately 1.5 months3
PK for plasma INCB161734: AUCinf
Defined as the area under concentration-time curve from time zero extrapolated to infinity.
Time frame
Up to approximately 1.5 monthsSecondary 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.
Time frame
Up to approximately 1.5 months and 15 days2
PK for plasma INCB161734: Tmax
Defined as the time to maximum concentration.
Time frame
Up to approximately 1.5 months3
PK for plasma INCB161734: t½
Defined as the terminal-phase half-life.
Time frame
Up to approximately 1.5 months4
PK for plasma INCB161734: Tlast
Defined as the time at which the last quantifiable concentration is observed.
Time frame
Up to approximately 1.5 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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