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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: ldalopirdine 120 mg; Drug: Idalopirdine 360 mg; Drug: Moxifloxacin 400 mg

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • FR801

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsules, orally, single dose
Experimental: Idalopirdine 120 mg; Therapeutic dosages	Drug: ldalopirdine 120 mg; Two 60 mg encapsulated film-coated tablets, orally, single dose
Experimental: Idalopirdine 360 mg; Supra-therapeutic dosages	Drug: Idalopirdine 360 mg; Four 90 mg encapsulated film-coated tablets, orally, single dose
Active Comparator: Moxifloxacin 400 mg; Positive Control	Drug: Moxifloxacin 400 mg; Encapsulated tablets, orally, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from pre-dose baseline in the QT interval (ΔQTcF) 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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 15689A; 2013-002387-12 (EudraCT Number)