HealthyPhase 1NCT02536209
A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
A Phase 1 study testing MT-8554 low dose, MT-8554 high dose and Oxycodone hydrochloride 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 pharmacodynamic effect of single doses of MT-8554 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT-8554 low dose, MT-8554 high dose and Oxycodone hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Nov 2015
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and free from clinically significant illness or disease
- Male Caucasian subjects aged 18 to 55
- A body weight of ≥60 kg
Who cannot join
- Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular 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
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
- Conditions
- Healthy
- Being tested
- MT-8554 low dose, MT-8554 high dose, Oxycodone hydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554 low doseDrug
MT-8554 high doseDrug
Oxycodone hydrochlorideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing Receives: Drug: MT-8554 low dose; Drug: MT-8554 high dose; Drug: Oxycodone hydrochloride; Drug: Placebo |
| Regimen 2 | Experimental | Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing Receives: Drug: MT-8554 low dose; Drug: MT-8554 high dose; Drug: Oxycodone hydrochloride; Drug: Placebo |
| Regimen 3 | Experimental | Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing Receives: Drug: MT-8554 low dose; Drug: MT-8554 high dose; Drug: Oxycodone hydrochloride; Drug: Placebo |
| Regimen 4 | Experimental | Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing Receives: Drug: MT-8554 low dose; Drug: MT-8554 high dose; Drug: Oxycodone hydrochloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
Measured: up to 10 hours post dosing
Secondary outcomes (7)
Safety and Tolerability as measured by vital signs
Measured: up to Day6 of treatment period 4
Safety and Tolerability as measured by ECG
Measured: up to Day6 of treatment period 4
Safety and Tolerability as measured by laboratory safety assessments
Measured: up to Day6 of treatment period 4
Safety and Tolerability as measured by physical examination
Measured: up to Day6 of treatment period 4
Safety and Tolerability as measured by number of participants with adverse events
Measured: up to Day6 of treatment period 4
Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments
Measured: up to 10 hours post dosing
Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments
Measured: up to 10 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 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
- NCT02536209
- Sponsor's protocol ID
- MT-8554-E03
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02536209
- Acronym / sponsor ID
- MT-8554-E03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Aug 2015 (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 pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 high dose, Drug: Oxycodone hydrochloride, Drug: PlaceboPeriod 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing |
| Regimen 2 | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 high dose, Drug: Oxycodone hydrochloride, Drug: PlaceboPeriod 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing |
| Regimen 3 | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 high dose, Drug: Oxycodone hydrochloride, Drug: PlaceboPeriod 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing |
| Regimen 4 | Experimental | Drug: MT-8554 low dose, Drug: MT-8554 high dose, Drug: Oxycodone hydrochloride, Drug: PlaceboPeriod 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy and free from clinically significant illness or disease
- Male Caucasian subjects aged 18 to 55
- A body weight of ≥60 kg
Key exclusion criteria (3 listed)
- Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular 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-8554 low dose | Drug | Regimen 1, Regimen 2, Regimen 3, Regimen 4 |
| MT-8554 high dose | Drug | Regimen 1, Regimen 2, Regimen 3, Regimen 4 |
| Oxycodone hydrochloride | Drug | Regimen 1, Regimen 2, Regimen 3, Regimen 4 |
| Placebo | Drug | Regimen 1, Regimen 2, Regimen 3, Regimen 4 |
Primary outcome
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
Time frame: up to 10 hours post dosing
7 secondary outcomes
Safety and Tolerability as measured by vital signs
Time frame: up to Day6 of treatment period 4
Safety and Tolerability as measured by ECG
Time frame: up to Day6 of treatment period 4
Safety and Tolerability as measured by laboratory safety assessments
Time frame: up to Day6 of treatment period 4
Safety and Tolerability as measured by physical examination
Time frame: up to Day6 of treatment period 4
Safety and Tolerability as measured by number of participants with adverse events
Time frame: up to Day6 of treatment period 4
Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments
Time frame: up to 10 hours post dosing
Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments
Time frame: up to 10 hours post 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 22 Dec 2025.
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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-8554 low dose, MT-8554 high dose and Oxycodone hydrochloride 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 22 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?
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test (time frame: up to 10 hours post dosing). 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 22 Dec 2025.