NCT02436486

CompletedPhase 1

Study Investigating the Effect of Idalopirdine on Cardiac Re...

H. Lundbeck A/S Source

H. Lundbeck A/S

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

15689A

Secondary identifiers

2013-002387-12

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

76

Locations

1 country

Sites

1

Timeline

Study Start

May 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2015

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 76 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2015
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 4, 2015
Actual (reported)
First Posted
May 6, 2015
Actual (reported)
Primary Completion
August 2015
Actual (reported)

Last Updated: September 22, 2015
Status Verified: September 2015
Last Update Submitted: September 21, 2015

Conditions

Healthy Volunteers

Outcome Measures

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)
For 24 hours in each dosing period

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Idalopirdine 120 mg

EXPERIMENTAL

Therapeutic dosages

Drug: ldalopirdine 120 mg

Idalopirdine 360 mg

EXPERIMENTAL

Supra-therapeutic dosages

Drug: Idalopirdine 360 mg

Interventions

PlaceboDrug

Capsules, orally, single dose

Placebo

ldalopirdine 120 mgDrug

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

Idalopirdine 120 mg

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

H. Lundbeck A/S
Industrylead

Study Sites (1)

FR801

Rennes, France

MeSH Terms

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amineMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
STUDY DIRECTOR

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 6, 2015

Study Start

May 2015

Date type not reported

This date has not been verified as actual or estimated.

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Moxifloxacin 400 mg

ACTIVE COMPARATOR

Positive Control

Drug: Moxifloxacin 400 mg

Idalopirdine 360 mgDrug

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

Idalopirdine 360 mg

Moxifloxacin 400 mgDrug

Encapsulated tablets, orally, single dose

Moxifloxacin 400 mg

Use of contraception.

You may not qualify if:

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.).

Contact the study team to confirm eligibility.

Primary Completion

August 2015

Actual (reported)

Last Updated

September 22, 2015

Record last verified: 2015-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02436486
Data provider: ClinicalTrials.gov
Source updated: 2015-09-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:32 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Placebo

Idalopirdine 120 mg

Idalopirdine 360 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Moxifloxacin 400 mg

You may not qualify if:

Source record

Locations