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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ACT-1014-6470 40 mg

• Registration Number: NCT04899219
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-06-16
• Status Verified: 2021-11
• Primary Completion: 2021-11-12
• Study Completion: 2021-11-12
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (control subjects)	ACT-1014-6470 40 mg	-
Group A (subjects with severe renal impairment)	ACT-1014-6470 40 mg	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

APEX GmbH; 🇩🇪 Munich, Germany