A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
NCT ID: NCT02841761
Last Updated: 2022-11-29
Study Results
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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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2016-07-01
2016-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Treatment A (Midazolam)
Single dose of Midazolam 8 mg on Day 1
Midalozam
Syrup for oral use
Treatment B1 (ACT-132577)
Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5.
Aprocitentan
Capsules for oral use
Treatment B2 (Midazolam + ACT-132577)
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Midalozam
Syrup for oral use
Aprocitentan
Capsules for oral use
Interventions
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Midalozam
Syrup for oral use
Aprocitentan
Capsules for oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests
Exclusion Criteria
18 Years
45 Years
MALE
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Investigator Site
Newark, New Jersey, United States
Countries
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Other Identifiers
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AC-080-103
Identifier Type: -
Identifier Source: org_study_id
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