MedTrace Logo

TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects

NCT04168723 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-02-20

No results posted yet for this study

Summary

This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects.

The planned enrollment is approximately 64 subjects randomized in a ratio of 1:1 to 2main groups. Subjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of 1:1.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MD1003

Group A: Daily dose of 1200 mg of MD1003 from Day 1 to Day 8

DRUG

Moxifloxacin 400mg

Group B1: Moxifloxacin 400 mg on Day 1 Group B2: Moxifloxacin 400 mg on Day 9

DRUG

Placebo for MD1003

Group A: Placebo for MD1003 on Day -1 Group B1: Placebo for MD1003 on Day -1 Group B2: Placebo for MD1003 on Day -1

DRUG

Placebo for moxifloxacin

Group A: Placebo for moxifloxacin on Day 1 and Day 9 Group B1: Placebo for moxifloxacin on Day 9 Group B2: Placebo for moxifloxacin on Day 1

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • MedDay Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Muna Albayaty, MD · Parexel Early Phase Clinical Unit London,Northwick Park Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2020-03-05
Completion
2020-03-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168723 on ClinicalTrials.gov