Healthy VolunteerPhase 1MT-7117 MBNCT03503266
Mass Balance Study With MT-7117
A Phase 1 study testing [14C] MT-7117 in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. at 1 site in United Kingdom.
Trial summary
This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 7117. 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 Volunteer
- What is being tested?
- [14C] MT-7117
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2018to 11 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 1. Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form, and after having the opportunity to discuss the study with the Investigator or designee.
- 2. Caucasian male subjects aged 30 to 65 years (inclusive) at Screening.
- 3. Healthy and free from illness or disease as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, laboratory and other tests at Screening and Day -1, unless deemed not clinically significant by the Investigator or designee.
- 4. Body weight of 60 to 110 kg (inclusive) and a body mass index (Quetelet index) ranging from 18 to 32 kg/m2 (inclusive) at Screening and Day -1.
- 5. Vital signs within the following ranges at Screening and Day -1:
- Systolic blood pressure: 90 to 140 mmHg
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- Diastolic blood pressure: 50 to 90 mmHg
- 6. Subjects and partners agree to use contraception throughout the study, as defined in the Protocol body.
- 7. Able to understand, in the Investigator's opinion, the nature of the study and any risks involved in participation and willing to cooperate and comply with the Protocol restrictions and requirements.
- 8. Regular daily bowel movements (i.e., production of at least one stool per day).
Who cannot join
- 1. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
- 2. Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives (whichever is longer) before the administration of IMP in this clinical study.
- 3. Consumption of any food-supplements, prescribed or over the counter medicine (including herbal and dietary supplements, such as St. John's Wort) during the 7 days (or 14 days if the medicine is a potential enzyme inducer) or five half-lives (whichever is longer) before the administration of IMP and during the study, unless in the opinion of the Sponsor and the Investigator, the medication will not interfere with the objectives of the study or compromise the subject's safety (Note: The use of acetaminophen [2 g/day for up to 3 consecutive days] will be permitted from Screening and during the study).
- 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal or renal disease, diabetes mellitus (type I and II), coronary heart disease, hypertension, or significant history of any psychiatric/psychotic disorder (including anxiety, depression and reactive depression).
- 5. Clinically relevant abnormal medical history, physical findings or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
- 6. Subjects with aspartate aminotransferase or alanine aminotransferase ≥2 x upper limit of normal or bilirubin above reference range at Screening or Day -1, confirmed by a repeat test at each visit.
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- 7. Has a positive hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) result at Screening.
- 8. Clinically significant abnormal 12-lead ECG findings, including subjects with corrected QT interval using Fridericia's formula (QTcF) of >450 ms, or presence of atrial fibrillation or other significant arrhythmia at Screening or Day -1, confirmed by repeat assessment.
- 9. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case of participation in the study. The Investigator should be guided by evidence of any of the following:
- history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
- history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection;
- history or clinical evidence of pancreatic injury or pancreatitis.
- 10. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks or chocolates (>5 cups of coffee or equivalent per day).
- 11. Consumption of food or drink containing grapefruit, poppy seeds or Seville oranges from 7 days before the administration of the IMP.
- 12. Presence or history (in the last 2 years) of alcohol abuse or weekly alcohol intake of more than 28 units (224 g) or a positive urine or breath alcohol test at Screening or Day 1. One unit (8 g) is equivalent to a ½ pint (280 mL) of beer, 1 measure (25 mL) of spirits or 1 small glass (125 mL) of wine.
- 13. Presence or history of drug abuse (as defined by Diagnostic and Statistical Manual of Mental Disorders [DSM-V] criteria) or a positive urine test for drugs of abuse at Screening or Day -1.
- 14. Donation of one or more units of blood (450 mL) within 3 months before the administration of the IMP, or plasma within 7 days prior to Screening, or platelets within 6 weeks prior to Screening or the intention to donate blood within 3 months after the final study visit.
- 15. Use of tobacco or nicotine-containing products (snuff, chewing tobacco, cigars, pipes, e cigarettes or nicotine replacement products) within the 3 month period prior to administration of IMP, during the confinement period and until the final study visit, or positive urine cotinine test at Screening or Day -1.
- 16. Heavy physical training or excessive exercise (e.g., long distance running, weight lifting or any physical activity to which the subject is not accustomed) from 7 days before the administration of IMP, during the participation in the study and for 7 days prior to any outpatient visit.
- 17. Family history of long QT syndrome or Torsades de Pointes.
- 18. Subjects with poor peripheral venous access.
- 19. Subjects who had a major surgical procedure or significant traumatic injury within 14 days prior to Day -1, or anticipation of the need for major surgery during the study period.
- 20. Subjects with creatinine clearance <60 mL/minute (calculated using Cockcroft-Gault formula) at Screening.
- 21. History of irritable bowel syndrome or other manifestation of abnormal bowel habit (e.g., diarrhoea, constipation).
- 22. Previous exposure to MT-7117 before the administration of IMP in this study.
- 23. 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 1999, shall participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-7117 After a Single Oral Dose to Healthy Male Subjects
This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 7117.
- Conditions
- Healthy Volunteer
- Being tested
- [14C] MT-7117
- Keywords
- Mass Balance Study with MT-7117
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] MT-7117Drug
14-C MT-7117
| Study group | Role | What they receive |
|---|---|---|
| [14C] MT-7117 | Experimental | 14-C MT-7117 Receives: Drug: [14C] MT-7117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - maximum observed plasma concentration (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
tmax - time at which Cmax occurs (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
AUC0 t - area under the plasma concentration time curve from time zero to the last measurable concentration (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
t½ - apparent terminal elimination half-life (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
Kel - terminal elimination rate constant (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
CL/F - apparent clearance (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
VZ/F - apparent volume of distribution (plasma and whole blood)
Measured: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
Total radioactivity in urine and faeces
Ae (urine), Ae (faeces) and Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined).
Measured: Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.
Total radioactivity in urine and faeces
%Ae (urine), %Ae (faeces) and %Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the dose.
Measured: Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.
Secondary outcomes (1)
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Measured: Up to 14 Days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start23 Mar 2018
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Mitsubishi Tanabe Pharma Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503266
- Sponsor's protocol ID
- MT-7117-E02
- Other IDs
- 2017-004549-25, 2017
- Acronym
- MT-7117 MB
- Status last verified
- May 2023
- First submitted
- 18 Mar 2018
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ogasawara A, Ide R, Inoue S, Tsuda M, Teng R. Assessment of Potential Drug-Drug Interactions for Novel Oral Melanocortin-1 Receptor Agonist Dersimelagon. Pharmacol Res Perspect. 2025 Feb;13(1):e70069. doi: 10.1002/prp2.70069.
PubMed 39887900
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-7117 After a Single Oral Dose to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03503266
- Acronym / sponsor ID
- MT-7117 MB / MT-7117-E02
- Conditions
- Healthy Volunteer
- Keywords
- Mass Balance Study with MT-7117
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 7117.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| [14C] MT-7117 | Experimental | Drug: [14C] MT-711714-C MT-7117 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form, and after having the opportunity to discuss the study with the Investigator or designee.
- 2. Caucasian male subjects aged 30 to 65 years (inclusive) at Screening.
- 3. Healthy and free from illness or disease as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, laboratory and other tests at Screening and Day -1, unless deemed not clinically significant by the Investigator or designee.
- 4. Body weight of 60 to 110 kg (inclusive) and a body mass index (Quetelet index) ranging from 18 to 32 kg/m2 (inclusive) at Screening and Day -1.
- 5. Vital signs within the following ranges at Screening and Day -1:
Key exclusion criteria (26 listed)
- 1. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
- 2. Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives (whichever is longer) before the administration of IMP in this clinical study.
- 3. Consumption of any food-supplements, prescribed or over the counter medicine (including herbal and dietary supplements, such as St. John's Wort) during the 7 days (or 14 days if the medicine is a potential enzyme inducer) or five half-lives (whichever is longer) before the administration of IMP and during the study, unless in the opinion of the Sponsor and the Investigator, the medication will not interfere with the objectives of the study or compromise the subject's safety (Note: The use of acetaminophen [2 g/day for up to 3 consecutive days] will be permitted from Screening and during the study).
- 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal or renal disease, diabetes mellitus (type I and II), coronary heart disease, hypertension, or significant history of any psychiatric/psychotic disorder (including anxiety, depression and reactive depression).
- 5. Clinically relevant abnormal medical history, physical findings or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
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] MT-711714-C MT-7117 | Drug | [14C] MT-7117 |
Primary outcome
Cmax - maximum observed plasma concentration (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
tmax - time at which Cmax occurs (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
AUC0 t - area under the plasma concentration time curve from time zero to the last measurable concentration (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
t½ - apparent terminal elimination half-life (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
Kel - terminal elimination rate constant (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
CL/F - apparent clearance (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
VZ/F - apparent volume of distribution (plasma and whole blood)
Time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.
Total radioactivity in urine and faeces
Time frame: Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.
Ae (urine), Ae (faeces) and Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined).
Total radioactivity in urine and faeces
Time frame: Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.
%Ae (urine), %Ae (faeces) and %Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the dose.
1 secondary outcome
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Time frame: Up to 14 Days after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 39887900Ogasawara A, Ide R, Inoue S, Tsuda M, Teng R. Assessment of Potential Drug-Drug Interactions for Novel Oral Melanocortin-1 Receptor Agonist Dersimelagon. Pharmacol Res Perspect. 2025 Feb;13(1):e70069. doi: 10.1002/prp2.70069.
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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.
General Manager study director
Mitsubishi Tanabe Pharma Europe Ltd
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] MT-7117 in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. 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 10 inclusion and 26 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 15 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax - maximum observed plasma concentration (plasma and whole blood) (time frame: at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503266, which also lists 1 linked publication.
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 15 May 2023.