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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708004
• Other study ID #: AC-080-102
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Aprocitentan
Formulated in capsules in 2 different strengths; 2 capsules per day

Other:
• Placebo
Matching active drug

Locations

Country	Name	City	State
Switzerland	Investigator Site Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	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
Other	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
Primary	Body weight	Change from baseline	from Day 1 to Day 9