NCT01338441

Brief Summary

The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

April 15, 2011

Last Update Submit

September 14, 2011

Conditions

Cardiology: RR / QT

Keywords

Drug induced QT prolongation

Outcome Measures

Primary Outcomes (1)

  • Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf

    Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.

    1hour and 20 minutes

Secondary Outcomes (2)

  • Comparison Delta QTcf eryhtromycin-sotalol

    over 3 hours

  • Assess the effect of erythromycin Twave morphologie changes

    1hour and 20 min

Study Arms (2)

Erythromycin

EXPERIMENTAL
Drug: Erythromycin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ErythromycinDRUG

4mg/Kg, IV during 20 min once

Erythromycin
PlaceboDRUG

4mg/Kg, IV during 20 min once

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 40 years of age
  • Caucasian origin
  • BMI 19 to 29 kg/m²
  • Informed Consent obtained
  • National Health Security Number
  • Eligible for Phase I as mentioned in the national registry of healthy volunteers
  • For woman: use of an effective contraceptive method
  • Asthma
  • Heart Rate \< 50 bpm
  • Hypotension with systolic blood pressure\< 100 mm Hg.
  • atrioventricular block (PR interval \> 200 ms)
  • Known Chronic illness (hepatic, renal or cardiac impairment, etc..)
  • Raynaud's phenomenon
  • Drug known to prolong QT (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days.
  • All chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the QT
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOTRIAL

Rueil-Malmaison, 92500, France

Location

Related Publications (1)

  • Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406.

    PMID: 28134617DERIVED

MeSH Terms

Interventions

Erythromycin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jean Sebastien Hulot, MD

    University PMCurrie-INSERM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 19, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

FR(1)