Healthy Subjects, Severe Renal Impairment
Conditions
Brief summary
The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
Interventions
DRUGACT-132577
Capsule
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
ALL SUBJECTS: * Signed informed consent in the local language prior to any study-mandated procedure; * Male/female aged 18 to 65 years (inclusive) at screening; * Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. Body weight at least 50 kg; * Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment. HEALTHY SUBJECTS: * Normal renal function confirmed by the estimated glomerular filtration rate (eGFR) determined at screening; * Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests. SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS: \- Severe renal function impairment is defined by eGFR estimated at screening between 15 mL/min/1.73 m2 and 29 mL/min/1.73 m2 (inclusive).
Exclusion criteria
ALL SUBJECTS: * Pregnant or lactating women; * Known hypersensitivity to ACT-132577 or drugs of the same class, or any of their excipients; * Known hypersensitivity or allergy to natural rubber latex; * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS: * End-stage renal disease that requires dialysis; * Hemoglobin concentration \< 9 g/dL; * History of severe renal stenosis; * Serum potassium concentration \> 5.5 mmol/L; * Presence of severe cardiac disease; * History of clinically relevant bleeding disorder; * Presence of any organ disorder, with the exception of renal function impairment, or use of any medication which might interfere with the pharmacokinetics of ACT-132577; * Known life-threatening disease with a life expectancy of less than 1 year; * Presence of unstable diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-132577 | From baseline to up to 16 days | Cmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of ACT-132577 | From baseline to up to 16 days | AUC(0-T) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] | From baseline to up to 16 days | AUC(0-inf) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events leading to premature discontinuation of study treatment | From baseline to up to 16 days | The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported |
| Time to reach Cmax (tmax) of ACT-132577 | From baseline to up to 16 days | tmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Incidence of any clinical relevant findings in ECG variables | From baseline to up to 16 days | The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported |
| Terminal half-life [t(1/2)] | From baseline to up to 16 days | t1/2 of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Incidence of treatment-emergent adverse events | From baseline to up to 16 days | The percentage of subjects with treatment-emergent adverse events will be reported |
Countries
Czechia
Outcome results
None listed