The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics

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sponsor

Idorsia Pharmaceuticals Ltd.

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Updated on 19 February 2024

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body mass index

hysterectomy

systolic blood pressure

renal function

serum pregnancy test

oophorectomy

follicle stimulating hormone

kidney function tests

cirrhosis

ovarian failure

diastolic blood pressure

renal function test

hepatic impairment

moderate hepatic impairment

bilateral salpingectomy

moderate hepatic insufficiency

aprocitentan

Summary

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).

Details

Condition	Healthy Subjects, Hepatic Impairment
Age	30years - 79years
Treatment	Aprocitentan
Clinical Study Identifier	NCT04252495
Sponsor	Idorsia Pharmaceuticals Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
	Women of childbearing potential (WoCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective methods of contraception from screening up to 30 days after study treatment
	A Women of non-childbearing potential (WoNCBP) must meet one of the following
	criteria
	Previous bilateral salpingectomy, salpingo-oophorectomy or hysterectomy
	Premature ovarian failure confirmed by a specialist gynecologist
	Post-menopausal, defined as 12 consecutive months with amenorrhea prior to screening without alternative medical cause and confirmed with a follicle-stimulating hormone test
	Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening
	Normal renal function confirmed by a creatinine clearance at screening according to Cockcroft and Gault adjusted to age
	Additional principal inclusion criteria for subjects with moderate hepatic impairment (Group 1)
	Moderate hepatic function impairment due to liver cirrhosis defined as a score of 7-9 (inclusive) according to the Child-Pugh classification
	Systolic blood pressure (SBP) 95 to 160 mmHg, diastolic blood pressure (DBP) 60 to 95 mmHg, and pulse rate 50 to 100 bpm (inclusive), measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 pre-dose
	International normalized ratio equal or less than 2.5 at screening
	Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1 and expected to be stable during the conduct of the study
	Additional principal inclusion criteria for healthy subjects (Group 2)
	Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests
Exclusion Criteria
	Pregnant or lactating women
	Previous exposure to aprocitentan and/or macitentan
	Known hypersensitivity to any excipients of the drug formulation
	Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
	Legal incapacity or limited legal capacity at screening
	Additional exclusion criteria for subjects with moderate hepatic impairment (Group 1)
	History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion (ADME) of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed)
	Hepatic cancer, primary biliary cirrhosis, or any form of cholestatic disease
	Clinical evidence or suspected acute liver failure as judged by the investigator
	Encephalopathy grade greater than 1
	Severe ascites and/or pleural effusion
	Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening & on Day -1, except for those related to liver cirrhosis
	Additional exclusion criteria for healthy subjects (Group 2)
	Clinically relevant findings on the physical examination at screening
	History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion (ADME) of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
	Clinically relevant findings in clinical laboratory tests (hematology, coagulation,clinical chemistry, and urinalysis) at screening & on Day -1
	Clinically relevant abnormalities on a 12-lead ECG, recorded after 5 min in the supine position at screening & on Day 1 pre-dose

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body mass index

hysterectomy

systolic blood pressure

renal function

serum pregnancy test

oophorectomy

follicle stimulating hormone

kidney function tests

cirrhosis

ovarian failure

diastolic blood pressure

renal function test

hepatic impairment

moderate hepatic impairment

bilateral salpingectomy

moderate hepatic insufficiency

aprocitentan

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The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics