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

Idorsia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ACT-1014-6470 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04899219

ID-087-104

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.