NCT02436486

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

May 4, 2015

Last Update Submit

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

Moxifloxacin 400 mg

ACTIVE COMPARATOR

Positive Control

Drug: Moxifloxacin 400 mg

Interventions

PlaceboDRUG

Capsules, orally, single dose

Placebo
ldalopirdine 120 mgDRUG

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

Idalopirdine 120 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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

FR801

Rennes, France

Location

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

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 1, 2015

Primary Completion

August 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

FR(1)