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Completed

NCT Number: NCT02436486

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

FR801

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Capsules, orally, single dose

ldalopirdine 120 mg

Drug

Two 60 mg encapsulated film-coated tablets, orally, single dose

Idalopirdine 360 mg

Drug

Four 90 mg encapsulated film-coated tablets, orally, single dose

Moxifloxacin 400 mg

Drug

Encapsulated tablets, orally, single dose

Primary outcomes

  1. Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period

    Time frame: For 24 hours in each dosing period

    The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
First posted
May 6, 2015
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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