At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
[14C]-MD1003drug
Likely dose
[14C]-MD1003 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating [14C]-MD1003 for Healthy Volunteers. Completed, enrolled 6 participants across 1 site.
Detailed Summary
This single-center, open-label, non randomized Phase I study is being conducted to investigate the pharmacokinetics, mass balance and metabolite profiling and identification after a single oral dose of 100mg of \[14C\]-MD1003 in 6 healthy males subjects. The radioactivity will be followed in the blood, urine and faeces to study MD1003 metabolism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
CollaboratorsQuotient Sciences
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedJan 2020
Primary CompletionJan 2020
TodayJul 2026
First PostedJan 10, 2020
Enrollment StartDec 10, 2019
Primary CompletionJan 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.5 years ago
Interventions
[14C]-MD1003drug
single oral dose of 100mg \[14C\]-MD1003