Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects

Phase 1

Completed

• Conditions: Renal Insufficiency; Healthy
• Interventions: Drug: ACT-541468

• Registration Number: NCT04024332
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-09-24
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (severe renal function impairment)	ACT-541468	On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.
Group A (healthy)	ACT-541468	On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.

Primary Outcome Measures

Name	Time	Method
AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf)	Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days

Secondary Outcome Measures

Name	Time	Method
Number of subjects with treatment-emergent (serious) adverse events (S)AEs	During treatment with ACT-541468 administration for a total duration of up to 4 days

Trial Locations

Locations (1)

APEX GmbH; 🇩🇪 München, Germany