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CompletedNCT02436486Updated Sep 22, 2015

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

A Phase 1 interventional study of Placebo and ldalopirdine 120 mg in Healthy Volunteers, sponsored by H. Lundbeck A/S. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-22.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts 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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Idalopirdine 120 mg

    Therapeutic dosages

    Drug: ldalopirdine 120 mg

  • Experimental
    Idalopirdine 360 mg

    Supra-therapeutic dosages

    Drug: Idalopirdine 360 mg

  • Active comparator
    Moxifloxacin 400 mg

    Positive Control

    Drug: Moxifloxacin 400 mg

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: For 24 hours in each dosing period

07

Study locations

1 site
  • FR801
    Rennes, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02436486
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
May 6, 2015
Start date
May 2015
Primary completion
Aug 2015
Last update
Sep 22, 2015

Study contacts

Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@Lundbeck.com

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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