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Healthy VolunteerPhase 1MT-8554 MBNCT03381404

Mass Balance Study With MT-8554

A Phase 1 study testing [14C] MT-8554 in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 8554. Read more about this study

Who is it for?
Ages 30 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
[14C] MT-8554
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
19 Dec 2017to 29 Jan 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 55 years
  • Men only
  • Healthy volunteers accepted
  • 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. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening and Day 1.
  • 3. Male Caucasian subjects, aged 30 to 55 years (inclusive) at Screening.
  • 4. A body weight of ≥60 kg and a body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive) at Screening or Day 1.
  • 5. Subjects and partners agree to use contraception throughout the study as detailed in the Protocol body.
  • 6. In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.
  • 7. Regular daily bowel movements (i.e., production of at least one stool per day).

Who cannot join

  • 1. Previously having received MT-8554.
  • 2. Participation in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks (or, if relevant, five half-lives, whichever is the longer) prior to dosing.
  • 3. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
  • 4. Subjects who have received any prescribed systemic or topical medication within 14 days (or, if relevant, five half-lives, whichever is longer) prior to dosing unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Subjects who have received slow release medicinal formulations considered to still be active within 14 days (or, if relevant, five half-lives, whichever is longer) prior to dosing will also be excluded unless, in the opinion of the Investigator or Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
  • 5. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days (or, if relevant, five half-lives, whichever is longer) prior to dosing unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety. Occasional use (2 g/day for 3 days) of paracetamol (acetaminophen) for mild analgesia is permitted.
  • 6. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days (or, if relevant, five half-lives, whichever is longer) prior to dosing unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
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  • 7. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal, renal, cardiovascular disease or history (within the last 2 years) of any significant psychiatric/psychotic illness disorder (including anxiety, depression and reactive depression).
  • 8. 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 compromise subject safety, as judged by the Investigator.
  • 9. Subjects with aspartate aminotransferase, alanine aminotransferase ≥1.5 × upper limit of normal or total bilirubin or creatine kinase above the reference range at Screening or Day 1.
  • 10. Subjects with creatinine clearance <60 mL/min (calculated using the Cockcroft-Gault-formula) at Screening.
  • 11. Family history of long or short QT syndrome, syncope of unknown cause or Torsades de Pointes.
  • 12. Clinically significant 12-lead electrocardiogram (ECG) abnormalities, including subjects with corrected QT interval using Fridericia's formula (QTcF) of >450 ms, at Screening or Day 1, confirmed by repeat assessment.
  • 13. Blood pressure (supine) at Screening or Day 1 outside the range of 90 to 140 mmHg (systolic) or 50 to 90 mmHg (diastolic) and pulse rate outside the range of 40 to 100 beats per minute, confirmed by repeat assessment. Evidence of postural hypotension at Screening defined as a decrease of >20 mmHg in systolic or >10 mmHg in diastolic blood pressure between the supine and standing position, confirmed by repeat assessment.
  • 14. Tympanic body temperature at Day 1 that is outside the local reference range (35.5°C to 37.8°C), confirmed by repeat assessment.
  • 15. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks or chocolates (≥5 cups of coffee or equivalent per day).
  • 16. 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.
  • 17. Presence or history (in the last 2 years) of alcohol abuse, or intake of more than 28 units/224 g of alcohol weekly or a positive breath test for alcohol at Screening or Day 1. One unit/8 g is equivalent to a half-pint (280 mL) of beer or one measure (25 mL) of spirits or one glass (125 mL) of wine.
  • 18. Subjects who use tobacco or nicotine-containing products (cigarettes, snuff, chewing tobacco, cigars, pipes, e cigarettes or nicotine-replacement products) within 3 months prior to dosing, or positive urine cotinine test at Screening or Day 1.
  • 19. Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody or human immunodeficiency virus (HIV) 1 and HIV 2 antibodies at Screening.
  • 20. Donate one or more units of blood (450 mL) within 3 months prior to Screening, or plasma within 7 days prior to Screening, or platelets within 6 weeks prior to Screening, or intention to donate blood within 3 months after the last scheduled visit.
  • 21. Consumption of food or drink containing red wine, Seville oranges (including marmalade), liquorice, cranberry (including fruit juice) or grapefruit (including fruit juice) from 7 days prior to Day 1.
  • 22. 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:
  • 23. History of irritable bowel syndrome, or other manifestation of abnormal bowel habit (e.g., diarrhoea, constipation);
  • 24. History of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding;
  • 25. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection;
  • 26. History or clinical evidence of pancreatic injury or pancreatitis.
  • 27. Radiation exposure, excluding background radiation but including that from the present study, 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.

United Kingdom1 site

  • Investigational center

    City Name

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About this study

Official title: An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-8554 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 8554.

Being tested
[14C] MT-8554
Keywords
Mass Balance Study with MT-8554

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C] MT-8554Drug

    14-C MT-8554

Study groups in NCT03381404
Study groupRoleWhat they receive
[14C] MT-8554ExperimentalNot described
Receives: Drug: [14C] MT-8554

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total radioactivity in urine and faeces

    Measured: Up to 14 Days after dosing

  2. Maximum observed plasma concentration [Cmax]

    Measured: Up to 14 Days after dosing

  3. Time at which Cmax occurs [tmax]

    Measured: Up to 14 Days after dosing

  4. Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-last]

    Measured: Up to 14 Days after dosing

  5. Apparent terminal elimination half-life [t1/2]

    Measured: Up to 14 Days after dosing

  6. Terminal elimination rate constant [Kel]

    Measured: Up to 14 Days after dosing

Secondary outcomes (2)

  1. Safety and tolerability as measured by adverse events (AEs)

    Measured: Up to 14 Days after dosing

  2. Safety and tolerability as measured by vital signs

    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.

  1. First posted22 Dec 2017
  2. Study start19 Dec 2017
  3. Primary completion29 Jan 2018
  4. Study completion29 Jan 2018

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381404
Sponsor's protocol ID
MT-8554-E07
Other IDs
2017-002830-21, 2017
Acronym
MT-8554 MB
Status last verified
Dec 2025
First submitted
29 Nov 2017
Last updated
17 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] MT-8554 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 7 inclusion and 27 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 17 Dec 2025. 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?

Total radioactivity in urine and faeces (time frame: Up to 14 Days after dosing). 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?

On the ClinicalTrials.gov record for NCT03381404.

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 17 Dec 2025.

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