Trial Outcomes & Findings for Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects (NCT NCT04223232)

NCT ID: NCT04223232

Last Updated: 2020-11-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Pre-dose to 312 hours post-dose
• Results posted on: 2020-11-02

Participant Flow

Participant milestones

Measure	MD1003 radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	MD1003 radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.3 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post-dose

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

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: CumAe (Urine)	70.9 mg equiv Standard Deviation 16.9

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post dose

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.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine)	70.786 percentage Standard Deviation 16.874

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post-dose

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.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: CumAe (Faeces)	16.0 mg equiv Standard Deviation 8.63

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post dose

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.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces)	16.009 percentage Standard Deviation 8.617

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post dose

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.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: CumAe(Total)	86.9 mg equiv Standard Deviation 9.25

PRIMARY outcome

Timeframe: Pre-dose to 312 hours post dose

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.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total)	86.795 percentage Standard Deviation 9.235

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	0.083 hours Interval 0.0 to 0.5
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	0.753 hours Interval 0.5 to 1.5
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	0.753 hours Interval 0.5 to 1.5
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	0.000 hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	2.086 hours Interval 1.52 to 3.0
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	4.011 hours Interval 3.0 to 6.0
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	2.667 hours Interval 2.0 to 4.0
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	2.667 hours Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	387 ng/mL Interval 325.0 to 416.0
Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	45.5 ng/mL Interval 26.4 to 59.0
Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	14.5 ng/mL Interval 9.7 to 18.9
Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	501 ng/mL Interval 469.0 to 543.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	3350 ng.h/mL Interval 2750.0 to 4480.0
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	514 ng.h/mL Interval 246.0 to 890.0
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	74.3 ng.h/mL Interval 47.4 to 123.0
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	2690 ng.h/mL Interval 2490.0 to 3310.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Population: For total radioactivity: for 3 patients, extrapolated portion of AUC(0-inf) \>20%.

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity MD1003	3650 ng.h/mL Interval 3010.0 to 4750.0
Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity Total radioactivity	2850 ng.h/mL Interval 2670.0 to 3060.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Population: For total radioactivity: for 3 patients, extrapolated portion of AUC(0-inf) \>20%.

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity MD1003	8.405 percentage of AUC(0-extrap) Interval 5.76 to 11.33
Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity Total radioactivity	15.171 percentage of AUC(0-extrap) Interval 10.15 to 18.82

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	1760 ng.h/mL Geometric Coefficient of Variation 16.50
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	279 ng.h/mL Geometric Coefficient of Variation 26.4
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	90.1 ng.h/mL Geometric Coefficient of Variation 23.7
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	2680 ng.h/mL Geometric Coefficient of Variation 10.6

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	0.02302 1/Hours Interval 0.018 to 0.0269
Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	0.02251 1/Hours Interval 0.0165 to 0.0285
Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	0.11829 1/Hours Interval 0.0324 to 0.1683
Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	0.20071 1/Hours Interval 0.0756 to 0.3762

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Plasma Clearance (CL/F) for MD1003	465 mL/min Interval 351.0 to 554.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Plasma Clearance (Vz/F) for MD1003	1230 L Interval 816.0 to 1560.0

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

Population: For Bisnorbiotin: terminal slopes could not be reliably determined for all, due to an unacceptable coefficient of determination (ie, R2 \< 0.9). For Biotin sulfoxide: terminal slopes could not be reliably determined all, due to an unacceptable coefficient of determination (ie, R2 \< 0.9) or insufficient data points after Cmax.

Measured at 0//1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity MD1003	30.625 hours Interval 25.74 to 38.51
Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Bisnorbiotin	33.176 hours Interval 24.29 to 42.065
Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Biotin Sulfoxide	10.010 hours Interval 4.12 to 21.42
Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Total radioactivity	4.502 hours Interval 1.84 to 9.17

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
MPR Cmax for Bisnorbiotin and Biotin Sulfoxide Bisnorbiotin	0.1327 none (ratio) Interval 0.074 to 0.174
MPR Cmax for Bisnorbiotin and Biotin Sulfoxide Biotin Sulfoxide	0.0349 none (ratio) Interval 0.028 to 0.044

SECONDARY outcome

Timeframe: Pre-dose to 168 hours

MPR = metabolite to parent ratio Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide Bisnorbiotin	0.1731 none (ratio) Interval 0.082 to 0.267
MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide Biotin sulfoxide	0.0204 none (ratio) Interval 0.014 to 0.026

SECONDARY outcome

Timeframe: Pre-dose to 168 hours post-dose

Total radioactivity in whole blood versus total radioactivity in plasma concentration ratios at time intervals following a single oral administration of 100mg [14C]-MD1003 Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Whole Blood: Plasma Concentration Ratios of Total Radioactivity 1 H	1.298 % radioactivity whole blood/plasma Geometric Coefficient of Variation 5.0
Whole Blood: Plasma Concentration Ratios of Total Radioactivity 4 H	0.931 % radioactivity whole blood/plasma Geometric Coefficient of Variation 14.6
Whole Blood: Plasma Concentration Ratios of Total Radioactivity 8 H	1.365 % radioactivity whole blood/plasma Geometric Coefficient of Variation 7.0
Whole Blood: Plasma Concentration Ratios of Total Radioactivity 12 H	1.708 % radioactivity whole blood/plasma Geometric Coefficient of Variation 9.3

SECONDARY outcome

Timeframe: Overall period

2 months

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Number of Subjects With Adverse Events (AEs)	2 Participants

SECONDARY outcome

Timeframe: Overall period

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Number of Subjects With Adverse Drug Reactions as Assessed by Investigator	0 Participants

SECONDARY outcome

Timeframe: Pre-dose to Day 10

Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Change From Baseline in Systolic Blood Pressure in mmHg 1H	0.7 mmHg Standard Deviation 4.9
Change From Baseline in Systolic Blood Pressure in mmHg 4H	-3.5 mmHg Standard Deviation 8.0
Change From Baseline in Systolic Blood Pressure in mmHg 24H	-1.0 mmHg Standard Deviation 10.3
Change From Baseline in Systolic Blood Pressure in mmHg 72H	-2.8 mmHg Standard Deviation 11.4
Change From Baseline in Systolic Blood Pressure in mmHg Discharge	0.5 mmHg Standard Deviation 6.9

SECONDARY outcome

Timeframe: Pre-dose to Day 10

Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Change From Baseline in Diastolic Blood Pressure in mmHg 1H	3.2 mmHg Standard Deviation 5.9
Change From Baseline in Diastolic Blood Pressure in mmHg 4H	2.5 mmHg Standard Deviation 6.1
Change From Baseline in Diastolic Blood Pressure in mmHg 24H	2.0 mmHg Standard Deviation 6.6
Change From Baseline in Diastolic Blood Pressure in mmHg 72H	-0.5 mmHg Standard Deviation 5.8
Change From Baseline in Diastolic Blood Pressure in mmHg Discharge	4.7 mmHg Standard Deviation 6.9

SECONDARY outcome

Timeframe: Pre-dose to Day 10

Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Change From Baseline in Heart Rate in Beats Per Minute 4H	-4.0 bpm Standard Deviation 4.8
Change From Baseline in Heart Rate in Beats Per Minute 1H	-3.7 bpm Standard Deviation 3.0
Change From Baseline in Heart Rate in Beats Per Minute 24H	-2.5 bpm Standard Deviation 5.5
Change From Baseline in Heart Rate in Beats Per Minute 72H	-2.0 bpm Standard Deviation 6.0
Change From Baseline in Heart Rate in Beats Per Minute Discharge	3.3 bpm Standard Deviation 9.9

SECONDARY outcome

Timeframe: Pre-dose to Day 10

Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.

Outcome measures

Measure	MD1003 n=6 Participants radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds 1H	2.2 msec Standard Deviation 6.9
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds 4H	2.7 msec Standard Deviation 3.9
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds 24H	1.0 msec Standard Deviation 4.6
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds Discharge	1.0 msec Standard Deviation 11.5

Adverse Events

MD1003

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MD1003 n=6 participants at risk radiolabeled 14C MD1003 (High Dose Biotin) 100mg \[14C\]-MD1003: single oral dose of 100mg \[14C\]-MD1003
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • From Day -28 to Day 8
Nervous system disorders Presyncope	16.7% 1/6 • Number of events 1 • From Day -28 to Day 8

Additional Information

Dr Frédéric SEDEL, Chief Scientific Officer and Co-founder

MedDay Pharmaceuticals

Phone: +33 1 80 40 14 40

Email: frederic.sedel@medday-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place