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Completed

NCT Number: NCT02708004

Clinical 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site Lausanne

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprocitentan

Drug

Formulated in capsules in 2 different strengths; 2 capsules per day

Other names: ACT-132577

Placebo

Other

Matching active drug

Primary outcomes

  1. Body weight

    Time frame: from Day 1 to Day 9

    Change from baseline

Other outcomes

  1. Treatment-emergent Adverse Events

    Time frame: From Day 1 up to End-of-Study (i.e. for at least 25 days)

    Number of subjects with Adverse Events

  2. Treatment-emergent Serious Adverse Events

    Time frame: From Screening (Day -3) up to Follow-up (i.e. for at least 49 days)

    Number of subjects with Serious Adverse Events

  3. Glomerular filtration rate (GFR)

    Time frame: At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9

    Change from baseline to each scheduled timepoint

  4. Fractional sodium excretion in 24 h urine samples [mmol per day]

    Time frame: At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9

    Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint

  5. Fractional lithium excretion in 24 h urine samples [mmol per day]

    Time frame: At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9

    Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2016
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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