Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
NCT ID: NCT02526888
Last Updated: 2018-07-10
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
14 participants
INTERVENTIONAL
2015-09-01
2015-11-01
Brief Summary
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Detailed Description
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Safety of the concomitant administration of the two drugs will also be assessed
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Sequence AB
During Period 1, subjects receive a single dose of ACT-541468 on Day 1. During Period 2, they receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4
ACT-541468
Oral capsule (25 mg) as single dose
Diltiazem
Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
Sequence BA
During Period 1, subjects receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4. During Period 2, they receive a single dose of ACT-541468 on Day 1
ACT-541468
Oral capsule (25 mg) as single dose
Diltiazem
Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
Interventions
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ACT-541468
Oral capsule (25 mg) as single dose
Diltiazem
Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests
Exclusion Criteria
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
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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Marie-Laure Boof, PhD
Role: STUDY_DIRECTOR
Actelion
Locations
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CRS Clinical Research Services Kiel GmbH
Kiel, , Germany
Countries
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Other Identifiers
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AC-078-103
Identifier Type: -
Identifier Source: org_study_id
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