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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708004
Other study ID # AC-080-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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