Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
Condition: Healthy Volunteers
Intervention: [14C]-MD1003
Intervention description: single oral dose of 100mg [14C]-MD1003
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males

          2. Age 30 to 65 years of age at the time of signing informed consent

          3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening

          4. Must be willing and able to communicate and participate in the whole study

          5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per
             day)

          6. Must provide written informed consent

          7. Must agree to adhere to the contraception requirements of the protocol

        Exclusion Criteria:

          1. Subjects who have received any IMP in a clinical research study within the 90 days
             prior to Day 1

          2. Subjects who are study site employees, or immediate family members of a study site or
             sponsor employee

          3. Subjects who have previously been enrolled in this study

          4. History of any drug or alcohol abuse in the past 2 years

          5. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25
             mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)

          6. A confirmed positive alcohol breath test at screening or admission

          7. Current smokers and those who have smoked within the last 12 months. A confirmed
             breath carbon monoxide reading of greater than 10 ppm at screening or admission

          8. Current users of e-cigarettes and nicotine replacement products and those who have
             used these products within the last 12 months

          9. Subjects with pregnant or lactating partners

         10. Radiation exposure, including that from the present study, excluding background
             radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv
             in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
             as defined in the Ionising Radiation Regulations 2017, shall participate in the study

         11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as
             assessed by the investigator or delegate at screening

         12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as
             judged by the investigator. Subjects with Gilbert's Syndrome are allowed

         13. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the
             protocol)

         14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
             human immunodeficiency virus (HIV) results

         15. Evidence of renal impairment at screening, as indicated by an estimated creatinine
             clearance of <80 mL/min using the Cockcroft-Gault equation

         16. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory
             or gastrointestinal disease, neurological or psychiatric disorder, as judged by the
             investigator

         17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation
             excipients

         18. Presence or history of clinically significant allergy requiring treatment, as judged
             by the investigator. Hay fever is allowed unless it is active

         19. Donation or loss of greater than 400 mL of blood within the previous 3 months

         20. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other
             than 4 g of paracetamol per day), herbal remedies, vitamin B5 or dietary supplements
             containing lipoic acid in the 14 days before IMP administration. Exceptions may apply
             on a case by case basis, if considered not to interfere with the objectives of the
             study, as determined by the PI

         21. Subjects who have had any intake of biotin (including as a nutritional supplement) in
             the 14 days before IMP administration

         22. Failure to satisfy the investigator of fitness to participate for any other reason