HealthyPhase 1NCT02834442
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects
A Phase 1 study testing MT-7117 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 safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT-7117
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy and free from clinically significant illness or disease
- Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
- A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2
Who cannot join
- Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
- Clinically relevant abnormal medical history, physical findings or laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.
- Conditions
- Healthy
- Being tested
- MT-7117, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-7117Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose, MT-7117 or Placebo | Experimental | Not described Receives: Drug: MT-7117; Drug: Placebo |
| Multiple ascending dose, MT-7117 or Placebo | Experimental | Not described Receives: Drug: MT-7117; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by number of participants with adverse events
Measured: up to Day56
Safety and Tolerability as measured by vital signs
Measured: up to Day56
Safety and Tolerability as measured by physical examination
Measured: up to Day56
Safety and Tolerability as measured by ECG
Measured: up to Day21
Safety and Tolerability as measured by laboratory safety assessments
Measured: up to Day21
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
Measured: 96 hours post dose
Area under the plasma concentration-time curve (AUC)
Measured: 96 hours post dose
Time to maximum plasma concentration (Tmax)
Measured: 96 hours post dose
Apparent elimination half-life in plasma
Measured: 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834442
- Sponsor's protocol ID
- MT-7117-E01
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2016
- Last updated
- 25 Jul 2017
- Results posted
- 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 39887900Ogasawara A, Ogawa K, Ide R, Ikenaga Y, Fukunaga C, Nakayama S, Tsuda M. Results from a first-in-human study of dersimelagon, an investigational oral selective MC1R agonist. Eur J Clin Pharmacol. 2023 Jun;79(6):801-813. doi: 10.1007/s00228-023-03476-6. Epub 2023 Apr 15.
PubMed 37060458
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02834442
- Acronym / sponsor ID
- MT-7117-E01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jul 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 safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose, MT-7117 or Placebo | Experimental | Drug: MT-7117, Drug: Placebo |
| Multiple ascending dose, MT-7117 or Placebo | Experimental | Drug: MT-7117, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy and free from clinically significant illness or disease
- Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
- A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2
Key exclusion criteria (3 listed)
- Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
- Clinically relevant abnormal medical history, physical findings or laboratory values
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-7117 | Drug | Multiple ascending dose, MT-7117 or Placebo, Single ascending dose, MT-7117 or Placebo |
| Placebo | Drug | Multiple ascending dose, MT-7117 or Placebo, Single ascending dose, MT-7117 or Placebo |
Primary outcome
Safety and Tolerability as measured by number of participants with adverse events
Time frame: up to Day56
Safety and Tolerability as measured by vital signs
Time frame: up to Day56
Safety and Tolerability as measured by physical examination
Time frame: up to Day56
Safety and Tolerability as measured by ECG
Time frame: up to Day21
Safety and Tolerability as measured by laboratory safety assessments
Time frame: up to Day21
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 96 hours post dose
Area under the plasma concentration-time curve (AUC)
Time frame: 96 hours post dose
Time to maximum plasma concentration (Tmax)
Time frame: 96 hours post dose
Apparent elimination half-life in plasma
Time frame: 96 hours post dose
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 25 Jul 2017.
- 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.
- Derived from this study: PubMed 37060458Ogasawara A, Ogawa K, Ide R, Ikenaga Y, Fukunaga C, Nakayama S, Tsuda M. Results from a first-in-human study of dersimelagon, an investigational oral selective MC1R agonist. Eur J Clin Pharmacol. 2023 Jun;79(6):801-813. doi: 10.1007/s00228-023-03476-6. Epub 2023 Apr 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-7117 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 3 inclusion and 3 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 25 Jul 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?
Safety and Tolerability as measured by number of participants with adverse events (time frame: up to Day56). The study lists 5 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 NCT02834442, which also lists 2 linked publications.
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 25 Jul 2017.