NCT02708004

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

February 24, 2016

Last Update Submit

November 22, 2022

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Change from baseline

    from Day 1 to Day 9

Other Outcomes (5)

  • Treatment-emergent Adverse Events

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

  • Treatment-emergent Serious Adverse Events

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

  • Glomerular filtration rate (GFR)

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

  • +2 more other outcomes

Study Arms (2)

ACT-132577

EXPERIMENTAL

3 different dose levels

Drug: Aprocitentan

Placebo

PLACEBO COMPARATOR

Matching active drug

Other: Placebo

Interventions

AprocitentanDRUG

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

Also known as: ACT-132577
ACT-132577
PlaceboOTHER

Matching active drug

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigator Site Lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

aprocitentan

Study Officials

  • Clinical Trial

    Idorsia Pharmaceuticals Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 15, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

CH(1)