NCT04252417

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: MedDay Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

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.

Conditions

• Healthy Volunteers
• Hepatic Impairment of Moderate Child Pugh Category

Interventions

Type	Name	Description
DRUG	MD1003	Single oral dose administration of MD1003 at Day 1

Timeline

• Start date: 2019-10-11
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2020-02-05
• Last updated: 2020-05-13

Locations

3 sites across 2 countries: France, Hungary