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

A Single-center, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Aprocitentan; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Investigator Site Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT-132577; 3 different dose levels	Drug: Aprocitentan; Formulated in capsules in 2 different strengths; 2 capsules per day; Other Names: ACT-132577
Placebo Comparator: Placebo; Matching active drug	Other: Placebo; Matching active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change from baseline	from Day 1 to Day 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent Adverse Events	Number of subjects with Adverse Events	From Day 1 up to End-of-Study (i.e. for at least 25 days)
Treatment-emergent Serious Adverse Events	Number of subjects with Serious Adverse Events	From Screening (Day -3) up to Follow-up (i.e. for at least 49 days)
Glomerular filtration rate (GFR)	Change from baseline to each scheduled timepoint	At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9
Fractional sodium excretion in 24 h urine samples [mmol per day]	Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint	At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9
Fractional lithium excretion in 24 h urine samples [mmol per day]	Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint	At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AC-080-102