Mass Balance Recovery, Metabolite Profile and Metabolite... | NCT04223232

NCT04223232

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Quotient Sciences	INDUSTRY

Label	Type	Description	Intervention Names
MD1003	Experimental	radiolabeled 14C MD1003 (High Dose Biotin) 100mg	Drug: [14C]-MD1003

Name	Type	Description	Arm Group Labels	Other Names
[14C]-MD1003	Drug	single oral dose of 100mg [14C]-MD1003	MD1003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mass Balance Recovery of Total Radioactivity: CumAe (Urine)	Cumulative amount of total radioactivity excreted in urine Measured at 0/12/24/48/72/96/120/144/168/192/216/240/264/288/312 hours	Pre-dose to 312 hours post-dose
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine)	Cumulative amount of total radioactivity excreted in urine expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.	Pre-dose to 312 hours post dose
Mass Balance Recovery of Total Radioactivity: CumAe (Faeces)	Cumulative amount of total radioactivity excreted in faeces Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.	Pre-dose to 312 hours post-dose
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces)	Cumulative amount of total radioactivity excreted in faeces expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.	Pre-dose to 312 hours post dose
Mass Balance Recovery of Total Radioactivity: CumAe(Total)	Cumulative amount of total radioactivity excreted in urine and faeces combined Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.	Pre-dose to 312 hours post dose
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total)	Cumulative amount of total radioactivity excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered Measured at 0/0.5/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168/192/216/240/264/288/312 hours.

Secondary Outcomes

Measure	Description	Time Frame
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity	Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.	Pre-dose to 168 hours
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males
Age 30 to 65 years of age at the time of signing informed consent
Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
Must be willing and able to communicate and participate in the whole study
Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
Must provide written informed consent
Must agree to adhere to the contraception requirements of the protocol

Exclusion Criteria:

Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
History of any drug or alcohol abuse in the past 2 years
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)
A confirmed positive alcohol breath test at screening or admission
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
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Subjects with pregnant or lactating partners
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
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed
Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the protocol)
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
Donation or loss of greater than 400 mL of blood within the previous 3 months
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
Subjects who have had any intake of biotin (including as a nutritional supplement) in the 14 days before IMP administration
Failure to satisfy the investigator of fitness to participate for any other reason

Name	Affiliation	Role
Somasekhara Menakuru, MS, MRCS	Quotient Sciences Nottingham, UK, NG116JS	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Sciences		Nottingham		NG11 6JS	United Kingdom

ID	Title	Description
FG000	MD1003	radiolabeled 14C MD1003 (High Dose Biotin) 100mg [14C]-MD1003: single oral dose of 100mg [14C]-MD1003

ID	Title	Description
BG000	MD1003	radiolabeled 14C MD1003 (High Dose Biotin) 100mg [14C]-MD1003: single oral dose of 100mg [14C]-MD1003

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mass Balance Recovery of Total Radioactivity: CumAe (Urine)

Cumulative amount of total radioactivity excreted in urine Measured at 0/12/24/48/72/96/120/144/168/192/216/240/264/288/312 hours

Posted

Mean

Standard Deviation

mg equiv

Pre-dose to 312 hours post-dose

ID	Title	Description
OG000	MD1003	radiolabeled 14C MD1003 (High Dose Biotin) 100mg [14C]-MD1003: single oral dose of 100mg [14C]-MD1003

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MD1003	radiolabeled 14C MD1003 (High Dose Biotin) 100mg [14C]-MD1003: single oral dose of 100mg [14C]-MD1003

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 12, 2019	Jul 28, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 2, 2019	Jul 28, 2020	SAP_001.pdf