Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects

Launched by MEDDAY PHARMACEUTICALS SA · Jan 7, 2020

Keywords

ClinConnect Summary

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Gender

MALE

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