NCT02537288

A Study in Healthy Volunteers to Assess the Effect of Fedovapagon on the QT/QTC Interval

A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

Detailed description

Regulatory guidance (ICH E14) has emphasized the need to obtain clear robust data on the effect of new chemical entities on ECG parameters with focus on cardiac repolarization as measured by the QTc duration. Though many Phase 1, 2 and 3 trials may be conducted they usually have insufficient sample size, infrequent sampling of ECG data, or the use of inadequate controls to overcome the high rate of spontaneous change in QTc duration. This has resulted in regulatory guidance recommending a dedicated or thorough trial to define the ECG effects of new drugs. This study will be conducted in healthy volunteers to eliminate variables known to have an effect on ECG parameters (concomitant drugs, diseases, etc.). A supra-therapeutic dose of fedovapagon is required to mimic the exposure in healthy volunteers that may occur in the target population under the worst of circumstances (e.g., concomitant use of CYP3A4 inhibitor, concomitant liver disease, presence of heart disease, taking more than the clinical dose prescribed, etc.) and to allow for PK to QTc modeling to assess the effect of drug concentration on cardiac repolarization. A cross-over trial is the preferred design as subjects act as their own controls and since there is no accumulation of any clinical relevance and the plasma concentration of parent dissipates before 24 hours, a single dose trial will be employed. During the course of the study each subject will be administered fedovapagon at both a clinical and supra-therapeutic dose, placebo and moxifloxacin (as a positive control). The sample size is driven by the need to do a time-matched statistical analysis on the primary endpoint as per ICH E14 guidance.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fedovapagon
DRUG	Moxifloxacin
DRUG	Placebo (for fedovapagon)

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-01
• Last updated: 2016-01-06

Locations

1 site across 1 country: Germany