HealthyPhase 1NCT02900235
Mass Balance Study of MT-3995
A Phase 1 study testing MT-3995 in people with Healthy, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects. Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT-3995
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Dec 2016
- 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 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent to participate in the study
- Caucasian male aged at least 35 years at Screening
- Healthy and free from clinically significant illness or disease at Screening and Day-1
- A body weight of 60 to 110 kg at Screening and Day-1
- Vital signs within the following ranges at Screening, Day-1 and Pre-dose:
- Body temperature : 35.0°C to 37.5°C
Show all 9Show fewer
- Systolic blood pressure: 90 to 140 mmHg
- Diastolic blood pressure: 50 to 90 mmHg
- Regular daily bowel movements
Who cannot join
- Presence or history of severe adverse reaction or allergy to any medicinal product
- Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives
- 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 considered clinically significant by the Investigator
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
- History or clinical evidence of pancreatic injury or pancreatitis
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-3995 After a Single Oral Dose to Healthy Male Subjects
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
- Conditions
- Healthy
- Being tested
- MT-3995
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3995Drug
| Study group | Role | What they receive |
|---|---|---|
| MT-3995 | Experimental | [14C]-MT-3995 after a single oral dose Receives: Drug: MT-3995 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in urine and faeces
Measured: up to 99 days
Maximum observed plasma concentration [Cmax]
Measured: up to 99 days
Time at which Cmax occurs [tmax]
Measured: up to 99 days
Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]
Measured: up to 99 days
Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]
Measured: up to 99 days
Apparent terminal elimination half-life [t1/2]
Measured: up to 99 days
Terminal elimination rate constant [Kel]
Measured: up to 99 days
Secondary outcomes (2)
Safety and tolerability as measured by adverse events (AEs)
Measured: up to 99 days
Safety and tolerability as measured by vital signs
Measured: up to 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900235
- Sponsor's protocol ID
- MT-3995-E11
- Status last verified
- Jan 2017
- First submitted
- 17 Aug 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. 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-3995 After a Single Oral Dose to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02900235
- Acronym / sponsor ID
- MT-3995-E11
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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.
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT-3995 | Experimental | Drug: MT-3995[14C]-MT-3995 after a single oral dose |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to provide written informed consent to participate in the study
- Caucasian male aged at least 35 years at Screening
- Healthy and free from clinically significant illness or disease at Screening and Day-1
- A body weight of 60 to 110 kg at Screening and Day-1
- Vital signs within the following ranges at Screening, Day-1 and Pre-dose:
Key exclusion criteria (6 listed)
- Presence or history of severe adverse reaction or allergy to any medicinal product
- Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives
- 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:
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 |
|---|---|---|
| MT-3995 | Drug | MT-3995 |
Primary outcome
Total radioactivity in urine and faeces
Time frame: up to 99 days
Maximum observed plasma concentration [Cmax]
Time frame: up to 99 days
Time at which Cmax occurs [tmax]
Time frame: up to 99 days
Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]
Time frame: up to 99 days
Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]
Time frame: up to 99 days
Apparent terminal elimination half-life [t1/2]
Time frame: up to 99 days
Terminal elimination rate constant [Kel]
Time frame: up to 99 days
2 secondary outcomes
Safety and tolerability as measured by adverse events (AEs)
Time frame: up to 99 days
Safety and tolerability as measured by vital signs
Time frame: up to 99 days
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 31 Jan 2017.
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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
Tanabe Pharma Corporation
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 MT-3995 in people with Healthy, run by Tanabe Pharma Corporation 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 9 inclusion and 6 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 31 Jan 2017. 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 99 days). The study lists 7 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 31 Jan 2017.