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HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects

NCT04252417 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-05-13

No results posted yet for this study

Summary

This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic function.

The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

Conditions

  • Healthy Volunteers
  • Hepatic Impairment of Moderate Child Pugh Category

Interventions

DRUG

MD1003

Single oral dose administration of MD1003 at Day 1

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • MedDay Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Yves Donazzolo, MD · Eurofins Optimed

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2020-03-17
Completion
2020-03-17

Countries

  • France
  • Hungary

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 NCT04252417 on ClinicalTrials.gov