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

NCT ID: NCT02708004

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2016-12-01

Brief Summary

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

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACT-132577

3 different dose levels

Group Type EXPERIMENTAL

Aprocitentan

Intervention Type DRUG

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

Placebo

Matching active drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching active drug

Interventions

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Aprocitentan

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

Intervention Type DRUG

Placebo

Matching active drug

Intervention Type OTHER

Other Intervention Names

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ACT-132577

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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Investigator Site Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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AC-080-102

Identifier Type: -

Identifier Source: org_study_id

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