Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Moxifloxacin 400 mg; Drug: ldalopirdine 120 mg; Drug: Idalopirdine 360 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436486

2013-002387-12 (EudraCT Number)

15689A

Details and patient eligibility

About

To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.

Enrollment: 76 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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76 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Idalopirdine 120 mg

Experimental group

Description:

Therapeutic dosages

Treatment:

Drug: ldalopirdine 120 mg

Idalopirdine 360 mg

Experimental group

Description:

Supra-therapeutic dosages

Treatment:

Drug: Idalopirdine 360 mg

Moxifloxacin 400 mg

Active Comparator group

Description:

Positive Control

Treatment:

Drug: Moxifloxacin 400 mg