Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441
NCT ID: NCT02479204
Last Updated: 2025-09-22
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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TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2015-04-28
2016-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Part A ACT-334441 + atenolol
4 subjects will receive 50 mg of atenolol once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6
ACT-334441 2 mg
capsule containing ACT-334441 at a strength of 2 mg
Atenolol
film-coated tablet containing atenolol at a strength of 50 mg
Part A ACT-334441 + diltiazem
4 subjects will receive 240 mg of diltiazem once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6
ACT-334441 2 mg
capsule containing ACT-334441 at a strength of 2 mg
Diltiazem ER
film-coated tablet containing diltiazem at a strength of of 120 mg
Part B ACT-334441 + atenolol
12 subjects will receive 50 mg of atenolol (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15
ACT-334441 4 mg
capsule containing ACT-334441 at a strength of 4 mg
Placebo
ACT-33441-matching placebo
Atenolol
film-coated tablet containing atenolol at a strength of 50 mg
Part B ACT-334441 + diltiazem
12 subjects will receive 240 mg of diltiazem (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15
ACT-334441 4 mg
capsule containing ACT-334441 at a strength of 4 mg
Placebo
ACT-33441-matching placebo
Diltiazem ER
film-coated tablet containing diltiazem at a strength of of 120 mg
Interventions
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ACT-334441 2 mg
capsule containing ACT-334441 at a strength of 2 mg
ACT-334441 4 mg
capsule containing ACT-334441 at a strength of 4 mg
Placebo
ACT-33441-matching placebo
Atenolol
film-coated tablet containing atenolol at a strength of 50 mg
Diltiazem ER
film-coated tablet containing diltiazem at a strength of of 120 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
* Women of childbearing potential must have a negative pregnancy test and they must use reliable methods of contraception
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests
Exclusion Criteria
* Any contraindication to the study drugs
* 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
* Any clinically significant abnormalities in laboratory tests, vital signs, ECG variables and pulmonary variables
* 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
25 Years
55 Years
ALL
Yes
Sponsors
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Viatris Innovation GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Viatris Innovation GmbH
Locations
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BIOTRIAL
Rennes, , France
Countries
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Other Identifiers
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AC-064-102
Identifier Type: -
Identifier Source: org_study_id
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