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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Other: Placebo; Drug: Aprocitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708004

AC-080-102

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

ACT-132577

Experimental group

Description:

3 different dose levels

Treatment:

Drug: Aprocitentan

Placebo

Placebo Comparator group

Description:

Matching active drug

Treatment:

Other: Placebo