A Nested Cross-Over TQT study to evaluate effect of MD1003 in HV
Research type
Research Study
Full title
A Phase 1, Single-Centre, 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
IRAS ID
271694
Contact name
Muna Albayaty
Contact email
Sponsor organisation
MedDay Pharmaceuticals S.A.
Eudract number
2019-003121-19
Duration of Study in the UK
0 years, 4 months, 8 days
Research summary
This is a single-centre, double-blind, randomised, placebo-controlled, parallel-group clinical trial to investigate the effects of repeated doses of the sponsor’s study drug, MD1003 (biotin), on heart function when given at an above-therapeutic dose level (1200 mg). The study design allows for assessment of how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]). The PK will be studied in connection with the effects on heart function. The study will also see how safe the study drug is after repeated doses of MD1003 1200 mg were taken. No genetic research will be performed in this study.
The study will comprise a screening visit, a treatment period and a follow-up visit at subject’s completion of the study.
A total of 64 healthy male and female subjects will be enrolled. Of these, 32 subjects will receive the active study drug (Subgroup A) and the other 32 subjects will receive the placebo of the study drug (Subgroup B). In addition, the subjects in Subgroup B will receive moxifloxacin and the placebo of moxifloxacin in a crossover way to evaluate the positive-control effect of moxifloxacin. To maintain the study’s blinding, a double-dummy design is employed whereby subjects in Subgroup A will also receive the placebo of moxifloxacin. The female volunteers in this study may be of childbearing potential.
This is not a first-in-human study as the study drug has been given to humans before. MD1003 (biotin), a water-soluble vitamin, is currently under development for the management of multiple sclerosis. The drug is thought to reverse the state of energy shortage in affected nerve cells and to contribute to repair of these cells. Moxifloxacin, a registered broad-spectrum antibiotic, is used in this trial as positive control to assess the sensitivity of the assay used for evaluation of the heart function data.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1447
Date of REC Opinion
30 Oct 2019
REC opinion
Further Information Favourable Opinion