NCT04223232 is a Phase 1 clinical trial of [14C]-MD1003 in Healthy Volunteers, sponsored by MedDay Pharmaceuticals SA.

Who is sponsoring NCT04223232?

NCT04223232 is sponsored by MedDay Pharmaceuticals SA.

What drugs are being tested in NCT04223232?

Interventions in NCT04223232: [14C]-MD1003.

What condition does NCT04223232 study?

NCT04223232 studies Healthy Volunteers.

Is NCT04223232 still recruiting?

NCT04223232 is currently completed. Last updated 2 November 2020.

Are results published for NCT04223232?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-02 · How we verify

NCT04223232

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 2 November 2020

What this trial tests

Phase 1 trial testing [14C]-MD1003 in Healthy Volunteers in 6 participants. Completed in 22 January 2020.

Timeline

10 December 2019

Primary endpoint
22 January 2020

22 January 2020

Quick facts

Lead sponsor	MedDay Pharmaceuticals SA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	6
Start date	10 December 2019
Primary completion	22 January 2020
Estimated completion	22 January 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

[14C]-MD1003 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

MedDay Pharmaceuticals SA — full company profile →

Who can join

Adults 30 to 65, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mass Balance Recovery of Total Radioactivity: CumAe (Urine) Primary · 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

Group	Value	95% CI
MD1003	70.9	± 16.9

Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine) Primary · 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.

Group	Value	95% CI
MD1003	70.786	± 16.874

Mass Balance Recovery of Total Radioactivity: CumAe (Faeces) Primary · 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.

Group	Value	95% CI
MD1003	16.0	± 8.63

Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces) Primary · 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.

Group	Value	95% CI
MD1003	16.009	± 8.617

Mass Balance Recovery of Total Radioactivity: CumAe(Total) Primary · 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.

Group	Value	95% CI
MD1003	86.9	± 9.25

Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total) Primary · 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.

Group	Value	95% CI
MD1003	86.795	± 9.235

Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	0.083	0.00 – 0.50

Bisnorbiotin

Group	Value	95% CI
MD1003	0.753	0.50 – 1.50

Biotin Sulfoxide

Group	Value	95% CI
MD1003	0.753	0.50 – 1.50

Total radioactivity

Group	Value	95% CI
MD1003	0.000	0.00 – 0.00

Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	2.086	1.52 – 3.00

Bisnorbiotin

Group	Value	95% CI
MD1003	4.011	3.00 – 6.00

Biotin Sulfoxide

Group	Value	95% CI
MD1003	2.667	2.00 – 4.00

Total radioactivity

Group	Value	95% CI
MD1003	2.667	2.00 – 4.00

Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	387	325 – 416

Bisnorbiotin

Group	Value	95% CI
MD1003	45.5	26.4 – 59.0

Biotin Sulfoxide

Group	Value	95% CI
MD1003	14.5	9.70 – 18.9

Total radioactivity

Group	Value	95% CI
MD1003	501	469 – 543

Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	3350	2750 – 4480

Bisnorbiotin

Group	Value	95% CI
MD1003	514	246 – 890

Biotin Sulfoxide

Group	Value	95% CI
MD1003	74.3	47.4 – 123

Total radioactivity

Group	Value	95% CI
MD1003	2690	2490 – 3310

Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	3650	3010 – 4750

Total radioactivity

Group	Value	95% CI
MD1003	2850	2670 – 3060

Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity Secondary · 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.

MD1003

Group	Value	95% CI
MD1003	8.405	5.76 – 11.33

Total radioactivity

Group	Value	95% CI
MD1003	15.171	10.15 – 18.82

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day -28 to Day 8. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MD1003

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (2 terms — click to expand)

Reaction	System	MD1003
Back pain	Musculoskeletal and connective tissue disorders	—
Presyncope	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04223232 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other MedDay Pharmaceuticals SA trials

Trials by the same sponsor.

NCT04168723 — TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects · Phase 1 · unknown
NCT04252417 — HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subject · Phase 1 · terminated
NCT04252430 — RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects · Phase 1 · terminated
NCT02967679 — SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04223232 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedDay Pharmaceuticals SA
Last refreshed: 2 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04223232.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04223232

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Healthy Volunteers

Other MedDay Pharmaceuticals SA trials

Verify against primary sources