Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects

NCT ID: NCT04024332

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2020-08-14

Brief Summary

Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects

Conditions

Renal Insufficiency; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A (healthy)

On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

ACT-541468 25 mg; administered orally

Group B (severe renal function impairment)

On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

ACT-541468 25 mg; administered orally

Interventions

ACT-541468

ACT-541468 25 mg; administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent in the local language prior to any study mandated procedure.
• Male and female subjects aged 18 to 85 years (inclusive) at screening.
• Body mass index (BMI) from 18 to 35 kg/m2 (inclusive) at screening. Body weight at least 50 kg.
• Women of childbearing potential: Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (during the entire study and 30 days thereafter) a highly effective method of contraception with a failure rate of < 1% per year.
• Women of non-childbearing potential, i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis: no contraceptive requirement.

• Normal renal function as confirmed based on Creatinine Clearance (CLcr) by the Cockcroft-Gault equation adjusted for age: >= 80 mL/min for subjects <= 50 years of age; >= 70 mL/min for subjects 51-60 years of age; >= 60 mL/min for subjects 61-85 years of age; CLcr = ([140-age(years)]×weight (kg))/(72×serum creatinine (mg/dL)) (x 0.85 for female subjects)
• The CLcr value should be confirmed (± 25%) on Day -1 in case subjects will be dosed more than 10 days after the day of screening.
• Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
• Each healthy subject must be matched with one subject with severe renal function impairment with regard to age (± 10 years difference allowed), body weight (± 15% difference allowed), and sex, determined by results at screening.

• Severe renal function impairment as confirmed based on CLcr by the Cockcroft-Gault equation: <30 mL/min, not on dialysis.
• The CLcr value should be confirmed (± 25%) on Day -1 since subjects will be dosed more than 10 days after the day of screening.
• Hematology, clinical chemistry, coagulation and urinalysis test results consistent with severe renal function impairment at screening.
• Physical examination without clinically relevant abnormalities at screening and on Day -1 (except for those related to severe renal function impairment), which would interfere with the objectives of the study.
• Stable concomitant medications.

Exclusion Criteria

• Pregnant or lactating women.
• Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal
• History of renal and/or liver transplant.
• Hepatic cancer, primary biliary cirrhosis or any form of cholestatic disease.
• Use of drugs which might interfere with the PK of ACT-541468 (moderate to strong CYP3A4 inhibitors or inducers).
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

• History or clinical evidence of any unstable disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy, herniotomy, and cholecystectomy allowed).
• Intake of any creatine supplement from screening to EOS.

• End-stage renal disease that requires dialysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

APEX GmbH

München, , Germany

Countries

Germany

Other Identifiers

2019-002159-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-078-115

Identifier Type: -

Identifier Source: org_study_id