Healthy
Conditions
Brief summary
An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects
Interventions
DRUGACT-1014-6470 40 mg
ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * Male or female subject aged at least 18 years at Screening. * Women of non-childbearing potential (e.g. post-menopausal) Additional inclusion criteria for subjects with severe renal impairment (Group A). \- Severe renal function impairment as confirmed at Screening based on an estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula of \< 30 mL/min (not on dialysis). Additional inclusion criteria for control subjects (Group B): * Normal renal function as confirmed at Screening based on eGFR. * Each control subject must be matched to the values of one subject with severe renal impairment based on age (±10 years difference allowed), BMI (±15% difference allowed), and sex, determined by results at Screening.
Exclusion criteria
\- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK of ACT-1014-6470 - Cmax | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). | For both Group A (subjects with severe renal impairment) and Group B (control subjects) |
Other
| Measure | Time frame | Description |
|---|---|---|
| PK of ACT-1014-6470 - Tmax | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). | For both Group A (subjects with severe renal impairment) and Group B (control subjects) |
| Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). | For both Group A (subjects with severe renal impairment) and Group B (control subjects) |
| Group B (control subjects): PK of ACT-1014-6470 - T1/2 | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). | For both Group A (subjects with severe renal impairment) and Group B (control subjects) |
Countries
Germany
Outcome results
None listed