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

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ClinicalTrials.gov Identifier: NCT02436486
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: ldalopirdine 120 mg Drug: Idalopirdine 360 mg Drug: Moxifloxacin 400 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Actual Primary Completion Date : August 2015

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




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436486


Locations
France
FR801
Rennes, France
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02436486     History of Changes
Other Study ID Numbers: 15689A
2013-002387-12 ( EudraCT Number )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors