Healthy Volunteers
Conditions
Brief summary
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
Interventions
DRUGPlacebo
Capsules, orally, single dose
DRUGldalopirdine 120 mg
Two 60 mg encapsulated film-coated tablets, orally, single dose
DRUGIdalopirdine 360 mg
Four 90 mg encapsulated film-coated tablets, orally, single dose
DRUGMoxifloxacin 400 mg
Encapsulated tablets, orally, single dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period | For 24 hours in each dosing period | The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF) |
Countries
France
Outcome results
None listed