Healthy VolunteersPhase 1NCT04223232
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
A Phase 1 study testing [14C]-MD1003 in people with Healthy Volunteers, run by MedDay Pharmaceuticals SA at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-MD1003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2019to 22 Jan 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
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
- Being tested
- [14C]-MD1003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-MD1003Drug
single oral dose of 100mg [14C]-MD1003
| Study group | Role | What they receive |
|---|---|---|
| MD1003 | Experimental | radiolabeled 14C MD1003 (High Dose Biotin) 100mg Receives: Drug: [14C]-MD1003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose to 312 hours post dose
Secondary outcomes (20)
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.
Measured: Pre-dose to 168 hours
Time of Maximum Plasma Concentration (Tmax) 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.
Measured: Pre-dose to 168 hours
Maximum Plasma Concentration (Cmax) 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.
Measured: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) 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.
Measured: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 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.
Measured: Pre-dose to 168 hours
Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 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.
Measured: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) 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.
Measured: Pre-dose to 168 hours
Lambda-z 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.
Measured: Pre-dose to 168 hours
Plasma Clearance (CL/F) for MD1003
Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.
Measured: Pre-dose to 168 hours
Plasma Clearance (Vz/F) for MD1003
Measured at 0/1/1.5/2/3/4/6/8/12/18/24/36/48/72/96/120/144/168 hours.
Measured: Pre-dose to 168 hours
Elimination Half Life (t1/2) 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.
Measured: Pre-dose to 168 hours
MPR Cmax for Bisnorbiotin and Biotin Sulfoxide
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.
Measured: Pre-dose to 168 hours
MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide
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.
Measured: Pre-dose to 168 hours
Whole Blood: Plasma Concentration Ratios of Total Radioactivity
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.
Measured: Pre-dose to 168 hours post-dose
Number of Subjects With Adverse Events (AEs)
2 months
Measured: Overall period
Number of Subjects With Adverse Drug Reactions as Assessed by Investigator
Measured: Overall period
Change From Baseline in Systolic Blood Pressure in mmHg
Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.
Measured: Pre-dose to Day 10
Change From Baseline in Diastolic Blood Pressure in mmHg
Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.
Measured: Pre-dose to Day 10
Change From Baseline in Heart Rate in Beats Per Minute
Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.
Measured: Pre-dose to Day 10
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds
Change from baseline measure (defined as Day 1, pre-dose). Measured at screening/Pre-dose/1/4/24/72/168 hours.
Measured: Pre-dose to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Dec 2019
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedDay Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, MS, MRCS, Principal investigator, Quotient Sciences Nottingham, UK, NG116JS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223232
- Sponsor's protocol ID
- MD1003CT2019-03MB
- Status last verified
- Oct 2020
- First submitted
- 13 Dec 2019
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04223232
- Acronym / sponsor ID
- MD1003CT2019-03MB
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MedDay Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MD1003 | Experimental | Drug: [14C]-MD1003radiolabeled 14C MD1003 (High Dose Biotin) 100mg |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-MD1003single oral dose of 100mg [14C]-MD1003 | Drug | MD1003 |
Primary outcome
Mass Balance Recovery of Total Radioactivity: CumAe (Urine)
Time frame: 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
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Urine)
Time frame: 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.
Mass Balance Recovery of Total Radioactivity: CumAe (Faeces)
Time frame: 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.
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Faeces)
Time frame: 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.
Mass Balance Recovery of Total Radioactivity: CumAe(Total)
Time frame: 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.
Mass Balance Recovery of Total Radioactivity: Cum%Ae (Total)
Time frame: 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.
20 secondary outcomes
Time Prior to the First Measurable Concentration (Tlag) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Time of Maximum Plasma Concentration (Tmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Maximum Plasma Concentration (Cmax) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-last)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time Extrapolated to Infinity (AUC(0-inf)) for MD1003 and Total Radioactivity
Time frame: Pre-dose to 168 hours
Percentage of AUC(0-extrap) Extrapolated Beyond the Last Measurable Concentration for MD1003 and Total Radioactivity
Time frame: Pre-dose to 168 hours
Area Under Plasma Concentration Curve From 0 Time to Last Measurable Concentration (AUC(0-12)) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Lambda-z for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
Plasma Clearance (CL/F) for MD1003
Time frame: Pre-dose to 168 hours
Plasma Clearance (Vz/F) for MD1003
Time frame: Pre-dose to 168 hours
Elimination Half Life (t1/2) for MD1003, Bisnorbiotin, Biotin Sulfoxide and Total Radioactivity
Time frame: Pre-dose to 168 hours
MPR Cmax for Bisnorbiotin and Biotin Sulfoxide
Time frame: Pre-dose to 168 hours
MPR AUC(0-inf) for Bisnorbiotin and Biotin Sulfoxide
Time frame: Pre-dose to 168 hours
Whole Blood: Plasma Concentration Ratios of Total Radioactivity
Time frame: Pre-dose to 168 hours post-dose
Number of Subjects With Adverse Events (AEs)
Time frame: Overall period
Number of Subjects With Adverse Drug Reactions as Assessed by Investigator
Time frame: Overall period
Change From Baseline in Systolic Blood Pressure in mmHg
Time frame: Pre-dose to Day 10
Change From Baseline in Diastolic Blood Pressure in mmHg
Time frame: Pre-dose to Day 10
Change From Baseline in Heart Rate in Beats Per Minute
Time frame: Pre-dose to Day 10
Change From Baseline in ECG (Electrocardiogram) QTcF Interval in Milliseconds
Time frame: Pre-dose to Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somasekhara Menakuru, MS, MRCS principal investigator
Quotient Sciences Nottingham, UK, NG116JS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-MD1003 in people with Healthy Volunteers, run by MedDay Pharmaceuticals SA at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass Balance Recovery of Total Radioactivity: CumAe (Urine) (time frame: Pre-dose to 312 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.