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

Healthy Volunteers Clinical Trial

Official title:

Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436486
• Other study ID #: 15689A
• Secondary ID: 2013-002387-12
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2015
• Last updated: September 21, 2015
• Start date: May 2015

Study information

• Verified date: September 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	FR801	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pre-dose baseline in the QT interval (?QTcF) at each post-dose time point within the ECG collection period	The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)	For 24 hours in each dosing period	Yes