NCT04252430

RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal 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 Renal Impaired Patients and Healthy Subjects With Normal Renal Function

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 renal impaired patients and healthy subjects with normal renal function. The planned enrollment is 36 subjects (18 impaired patients and 18 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 18 healthy male volunteers and in 18 renal impaired patients. It is planned to enroll a total of 36 subjects to receive a single oral dose of investigational medicinal product (IMP): * 6 patients with mild renal impaired function, 6 patients with moderate renal impaired function and 6 patients with severe renal impaired function will be enrolled in four Hungarian centers; * 18 Healthy volunteers will be enrolled by Eurofins Optimed in Gières, France. Healthy volunteers will be matched with impaired renal function patients on ethnic group, sex, age and BMI. Subjects will be screened for eligibility to participate in the study up to 21 days prior to the first administration. For both arms, subjects will be admitted into the Clinical Research Unit (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). Subjects 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, 168 hours post-dose). Urine sample draws for measurement of MD1003 and its main metabolites will also be taken throughout the study (pre-dose, \]D1T0h - D1T4h\], \]D1T4h - D1T8h\], \]D1T8h - D1T12h\], \]D1T12h - D2T24h\], \]D2T24h - D2T36h\], \]D2T36h - D3T48h\], \]D3T48h - D4T72h\], \]D4T72h - D5T96h\], \]D5T96h - D6T120h\], \]D6T120h - D7T144h\], \]D7T144h - D8T168h\] post-dose). Then, subjects will come back to the CRU for 4 ambulatory visits on Day 10, Day 12, Day 14 and Day 16 for blood sampling (respectively 216, 264, 312, 360 hours post dose). A follow-up post study visit will occur on Day 23 (±2 days) post-dose to ensure the ongoing wellbeing of the subjects. Adverse events (AEs), clinical laboratory evaluations, vital signs assessments, 12-lead ECG 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
• Impaired Renal Function

Interventions

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

Timeline

• Start date: 2019-10-09
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2020-02-05
• Last updated: 2020-05-13

Locations

5 sites across 2 countries: France, Hungary