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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT02436486 |
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Date of registration:
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04/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
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Scientific title:
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Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02436486 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Email contact via H. Lundbeck A/S |
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Address:
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Telephone:
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Email:
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Affiliation:
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LundbeckClinicalTrials@Lundbeck.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and
physical examination
- Use of contraception.
Exclusion Criteria:
- The subject has evidence of cardiac conduction abnormalities as calculated by the ECG
equipment and evaluated by the investigator, at the Screening Visit or at the
Baseline visit
- 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.).
Other protocol defined inclusion and exclusion criteria do apply
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: ldalopirdine 120 mg
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Drug: Moxifloxacin 400 mg
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Drug: Idalopirdine 360 mg
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Drug: Placebo
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Primary Outcome(s)
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Change from pre-dose baseline in the QT interval (?QTcF) at each post-dose time point within the ECG collection period
[Time Frame: For 24 hours in each dosing period]
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Secondary ID(s)
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2013-002387-12
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15689A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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