A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects

Study Overview
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Brief Summary
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An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects

Official Title
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An Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACT-1014-6470 40 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (subjects with severe renal impairment)<br> | Drug: ACT-1014-6470 40 mg<br>* ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.<br>|
| Experimental: Group B (control subjects)<br> | Drug: ACT-1014-6470 40 mg<br>* ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of ACT-1014-6470 - Cmax | For both Group A (subjects with severe renal impairment) and Group B (control subjects) | 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). |