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

NCT ID: NCT04223232

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2020-01-22

Brief 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

MD1003

radiolabeled 14C MD1003 (High Dose Biotin) 100mg

Group Type: EXPERIMENTAL

[14C]-MD1003

Intervention Type: DRUG

single oral dose of 100mg \[14C\]-MD1003

Interventions

[14C]-MD1003

single oral dose of 100mg \[14C\]-MD1003

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

MedDay Pharmaceuticals SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Somasekhara Menakuru, MS, MRCS

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences Nottingham, UK, NG116JS

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MD1003CT2019-03MB

Identifier Type: -

Identifier Source: org_study_id