Completed PHASE1 INTERVENTIONAL 7-arm NCT02091310

Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers

A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.

Sponsor: CardiaBase

Conditions Healthy Volunteers

Interventions GFT505 Moxifloxacin 400 mg Placebo

Updated 6 times since 2017 Last updated: Mar 9, 2015 Started: Feb 28, 2014 Primary completion: Dec 31, 2014 Completion: Feb 28, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Healthy Volunteers, this trial is completed. The trial is conducted by CardiaBase and has accumulated 6 data snapshots since 2014. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Feb 2023 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Feb 2023 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Feb 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

CardiaBase
Eurofins Optimed
Genfit
PhinC Development

Data source: Genfit

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Gières, France