Status:
COMPLETED
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
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Renal Insufficiency
Healthy
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- General inclusion criteria for all subjects:
- 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.
- Additional inclusion criteria for healthy subjects (Group A):
- 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.
- Additional inclusion criteria for subjects with severe renal function impairment (Group B)
- 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.
- General exclusion criteria for all subjects:
- 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.
- Additional exclusion criteria for healthy subjects (Group A)
- 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.
- Additional exclusion criteria for subjects with severe renal function impairment (Group B).
- \- End-stage renal disease that requires dialysis.
Exclusion
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04024332
Start Date
September 24 2019
End Date
August 14 2020
Last Update
September 3 2020
Active Locations (1)
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1
APEX GmbH
München, Germany, 81241