Healthy Volunteers Clinical Trial
Official title:
Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Hepatic Impaired Patients and Healthy Subjects With Normal Hepatic Function
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).
The study is a multicentric, open label, phase I, two arms study to compare pharmacokinetics
of MD1003 after a single oral dose of MD1003 100 mg in eight (8) healthy male/female subjects
and eight (8) male/female patients of moderate Child Pugh category. Healthy subjects and
patients will receive a single oral dose of MD1003 100 mg. The healthy subjects will match
with impaired hepatic function patients on ethnic group, sex, age (+/- 10 years) and BMI (+/-
20%).
Participants will be admitted into the Clinical Research Units (CRU) on Day-3. On the morning
of Day 1, subjects will receive a single 100 mg oral dose of MD1003 following an overnight
fast (i.e., at least 10 hours). Participants will be confined to the CRU until discharge on
Day 8, with PK blood sample draws for measurement of MD1003 and its main metabolites being
taken throughout the confinement (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36,
48, 72, 96, 120, 144, 168h post dose). A Follow up post study visit will occur on Day 14 (± 2
days).
Adverse events (AEs), clinical laboratory evaluations, vital signs assessments, 12-lead
electrocardiograms (ECGs), and physical examination (PE) findings will be monitored at
Screening and at specified times during the study. All AEs will be recorded throughout the
study (i.e., from signing of the Informed Consent Form until Study Completion).
The Study Completion is defined as the last subject's end-of-study assessment.
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