Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
NCT ID: NCT02436486
Last Updated: 2015-09-22
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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COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Capsules, orally, single dose
Idalopirdine 120 mg
Therapeutic dosages
ldalopirdine 120 mg
Two 60 mg encapsulated film-coated tablets, orally, single dose
Idalopirdine 360 mg
Supra-therapeutic dosages
Idalopirdine 360 mg
Four 90 mg encapsulated film-coated tablets, orally, single dose
Moxifloxacin 400 mg
Positive Control
Moxifloxacin 400 mg
Encapsulated tablets, orally, single dose
Interventions
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Placebo
Capsules, orally, single dose
ldalopirdine 120 mg
Two 60 mg encapsulated film-coated tablets, orally, single dose
Idalopirdine 360 mg
Four 90 mg encapsulated film-coated tablets, orally, single dose
Moxifloxacin 400 mg
Encapsulated tablets, orally, single dose
Eligibility Criteria
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Inclusion Criteria
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination
* Use of contraception.
Exclusion Criteria
* The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).
18 Years
45 Years
MALE
Yes
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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FR801
Rennes, , France
Countries
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Other Identifiers
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2013-002387-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15689A
Identifier Type: -
Identifier Source: org_study_id
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