Healthy VolunteerPhase 1MT-8554 DQTNCT03471130
Definitive QT Study With MT-8554
A Phase 1 study testing MT-8554 Low dose and MT-8554 High dose in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. at 1 site in United Kingdom.
Trial summary
This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF) from Baseline in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MT-8554 Low dose and MT-8554 High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2018to 19 Oct 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Provide written informed consent to participate in this study.
- 2. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination (PE), laboratory, and other tests at Screening and Admission.
- 3. Male and female subjects, aged 18 to 55 years (inclusive) at Screening.
- 4. A body weight of ≥60 kg male and ≥50 kg female and a body mass index ranging from 18 to 30 kg/m2 (inclusive) at Screening.
- 5. Subjects and partners agree to use contraception throughout the study as detailed in the protocol.
- 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.
Who cannot join
- 1. Subjects with PR >240 ms, QRS ≥120 ms or corrected QT interval (QTc) by Fridericia's correction >450 ms for males and >470 ms for females on the Screening ECG, or any clinically significant ECG abnormality, in the opinion of the Investigator.
- 2. Subjects who have a history of cardiac disease or arrhythmias that can cause QTc prolongation.
- 3. Family history of long or short QT syndrome, hypokalaemia, syncope, or Torsades de Pointes.
- 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal (GI), renal (including estimated glomerular filtration rate <90 mL/min), cardiovascular disease, or history (within the last 2 years) of any significant psychiatric/psychotic illness 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. Previously having received MT-8554.
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- 7. Participation in more than 3 clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks (or if relevant, 5 half-lives, whichever is longer) prior to the first dose.
- 8. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
- 9. Subjects who have received any prescribed systemic or topical medication within 14 days (or if relevant, 5 half-lives; whichever is longer) prior to the first dose of IMP 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, 5 half-lives; whichever is longer) prior to the first dose administration will also be excluded unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
- 10. 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 the first dose of IMP unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Occasional use of paracetamol (acetaminophen) for mild analgesia is permitted.
- 11. 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, 5 half lives; whichever is longer) prior to the first dose of IMP unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety.
- 12. Subjects with aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥1.5×upper limit of normal (ULN) or total bilirubin or creatine kinase above the reference range at Screening or Day -1.
- 13. Blood pressure (BP, supine) at Screening or Day -1 outside the range 90 to 140 mmHg (systolic) or 50 to 90 mmHg (diastolic); and pulse rate outside the range of 40 to 100 beats per minute (bpm), confirmed by repeat assessment. Evidence of postural hypotension defined as a decrease of >20 mmHg in systolic bp or >10 mmHg in diastolic bp between the supine and standing position, confirmed by repeat assessment.
- 14. Tympanic body temperature at Day -1 that is outside the local reference range, confirmed by repeat assessment.
- 15. Subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.
- 16. Presence or history of lactose intolerance.
- 17. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks or chocolates (>5 cups of coffee or equivalent per day).
- 18. 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.
- 19. Presence or history (in the last 2 years) of alcohol abuse, or intake of more than 28 units/224 g of alcohol weekly (for men) or 21 units/168 g of alcohol weekly (for women) 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, 1 measure (25 mL) of spirits, or 1 glass (125 mL) of wine.
- 20. 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.
- 21. Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 \& HIV 2 antibodies at Screening.
- 22. Donate ≥1 units of blood (450 mL) in the 3 months prior to Screening, plasma in the 7 days prior to Screening, platelets in the 6 weeks prior to Screening, or intention to donate blood within 3 months after the last scheduled visit.
- 23. Consumption of food or drink containing Seville oranges, cranberry, liquorice or grapefruit from 7 days prior to Day -1.
- 24. 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 or participation in the study. The Investigator should be guided by evidence of any of the following histories:
- Inflammatory bowel syndrome, gastritis, ulcers, GI or rectal bleeding
- Major GI surgery such as gastrectomy, gastroenterostomy, or bowel resection
- Clinical evidence of pancreatic injury or pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of MT-8554 at Two Dose Levels, MT-8554 Low Dose and MT-8554 High Dose, on the QT/QTc Interval in Healthy Adult Subjects
This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF) from Baseline in healthy adult subjects
- Conditions
- Healthy Volunteer
- Being tested
- MT-8554 Low dose, MT-8554 High dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554 Low doseDrug
Oral, 7 days
MT-8554 High doseDrug
Oral, 7 days
PlaceboDrug
Oral, 7 days
| Study group | Role | What they receive |
|---|---|---|
| Low dose MT-8554 or placebo to match | Experimental | Low dose MT-8554 Receives: Drug: MT-8554 Low dose; Drug: Placebo |
| High dose MT-8554 or placebo to match | Experimental | High dose MT-8554 Receives: Drug: MT-8554 High dose; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF with placebo adjustment
Measured: Days 1 & 7
Secondary outcomes (5)
Proportion of subjects with changes to QTcF from Baseline exceeding >30ms
Measured: Days 1 & 7
Proportion of subjects with changes to QTcF from Baseline exceeding >60ms
Measured: Days 1 & 7
Change in Heart Rate compared to baseline
Measured: Days 1 & 7
Change in PR Interval compared to baseline
Measured: Days 1 & 7
Change in QRS duration compared to baseline
Measured: Days 1 & 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start23 Apr 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Science, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471130
- Sponsor's protocol ID
- MT-8554-E08
- Other IDs
- 2017-004138-27, 2017
- Acronym
- MT-8554 DQT
- Status last verified
- Dec 2025
- First submitted
- 28 Feb 2018
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of MT-8554 at Two Dose Levels, MT-8554 Low Dose and MT-8554 High Dose, on the QT/QTc Interval in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03471130
- Acronym / sponsor ID
- MT-8554 DQT / MT-8554-E08
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 20 Mar 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 study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF) from Baseline in healthy adult subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Low dose MT-8554 or placebo to match | Experimental | Drug: MT-8554 Low dose, Drug: PlaceboLow dose MT-8554 |
| High dose MT-8554 or placebo to match | Experimental | Drug: MT-8554 High dose, Drug: PlaceboHigh dose MT-8554 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Provide written informed consent to participate in this study.
- 2. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination (PE), laboratory, and other tests at Screening and Admission.
- 3. Male and female subjects, aged 18 to 55 years (inclusive) at Screening.
- 4. A body weight of ≥60 kg male and ≥50 kg female and a body mass index ranging from 18 to 30 kg/m2 (inclusive) at Screening.
- 5. Subjects and partners agree to use contraception throughout the study as detailed in the protocol.
Key exclusion criteria (27 listed)
- 1. Subjects with PR >240 ms, QRS ≥120 ms or corrected QT interval (QTc) by Fridericia's correction >450 ms for males and >470 ms for females on the Screening ECG, or any clinically significant ECG abnormality, in the opinion of the Investigator.
- 2. Subjects who have a history of cardiac disease or arrhythmias that can cause QTc prolongation.
- 3. Family history of long or short QT syndrome, hypokalaemia, syncope, or Torsades de Pointes.
- 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal (GI), renal (including estimated glomerular filtration rate <90 mL/min), cardiovascular disease, or history (within the last 2 years) of any significant psychiatric/psychotic illness 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 |
|---|---|---|
| MT-8554 Low doseOral, 7 days | Drug | Low dose MT-8554 or placebo to match |
| MT-8554 High doseOral, 7 days | Drug | High dose MT-8554 or placebo to match |
| PlaceboOral, 7 days | Drug | High dose MT-8554 or placebo to match, Low dose MT-8554 or placebo to match |
Primary outcome
Change from baseline in QTcF with placebo adjustment
Time frame: Days 1 & 7
5 secondary outcomes
Proportion of subjects with changes to QTcF from Baseline exceeding >30ms
Time frame: Days 1 & 7
Proportion of subjects with changes to QTcF from Baseline exceeding >60ms
Time frame: Days 1 & 7
Change in Heart Rate compared to baseline
Time frame: Days 1 & 7
Change in PR Interval compared to baseline
Time frame: Days 1 & 7
Change in QRS duration compared to baseline
Time frame: Days 1 & 7
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 17 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.
Head of Medical Science study director
Tanabe Pharma America, Inc.
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 and MT-8554 High dose 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 6 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?
Change from baseline in QTcF with placebo adjustment (time frame: Days 1 & 7). 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 17 Dec 2025.