Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Placebo; Drug: Aprocitentan

• Registration Number: NCT02708004
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Study Start: 2016-06-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Signed informed consent
• Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests
• Body mass index between 20.0 and 25.0 kg/m2 (inclusive) 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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching active drug
ACT-132577	Aprocitentan	3 different dose levels

Primary Outcome Measures

Name	Time	Method
Body weight	from Day 1 to Day 9	Change from baseline

Trial Locations

Locations (1)

Investigator Site Lausanne; 🇨🇭 Lausanne, Switzerland