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Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects

NCT04223232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-02

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-MD1003

single oral dose of 100mg \[14C\]-MD1003

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • MedDay Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Somasekhara Menakuru, MS, MRCS · Quotient Sciences Nottingham, UK, NG116JS

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2020-01-22
Completion
2020-01-22

Countries

  • United Kingdom

Study Locations

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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 NCT04223232 on ClinicalTrials.gov