Definitive QT Study With MT-8554

NCT03471130 | Completed Phase 1

• 2 other identifiers: MT-8554-E082017-004138-27
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QTcF with placebo adjustment

  Days 1 & 7

Secondary Outcomes (5)

• Proportion of subjects with changes to QTcF from Baseline exceeding >30ms

  Days 1 & 7

• Proportion of subjects with changes to QTcF from Baseline exceeding >60ms

  Days 1 & 7

• Change in Heart Rate compared to baseline

  Days 1 & 7

• Change in PR Interval compared to baseline

  Days 1 & 7

• Change in QRS duration compared to baseline

  Days 1 & 7

Other Outcomes (3)

• Plasma concentration of MT-8554 with respect to time

  Days 1 & 7

• Plasma concentration of metabolite with respect to time

  Days 1 & 7

• Number of participants with treatment related adverse events

  Days 1 to 9

Study Arms (2)

Low dose MT-8554 or placebo to match

EXPERIMENTAL

Low dose MT-8554

Drug: MT-8554 Low dose; Drug: Placebo

High dose MT-8554 or placebo to match

EXPERIMENTAL

High dose MT-8554

Drug: MT-8554 High dose; Drug: Placebo

Interventions

MT-8554 Low dose DRUG

Oral, 7 days

Low dose MT-8554 or placebo to match

MT-8554 High dose DRUG

Oral, 7 days

High dose MT-8554 or placebo to match

Placebo DRUG

Oral, 7 days

High dose MT-8554 or placebo to match; Low dose MT-8554 or placebo to match

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Provide written informed consent to participate in this study.
• \. 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.
• \. Male and female subjects, aged 18 to 55 years (inclusive) at Screening.
• \. 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.
• \. Subjects and partners agree to use contraception throughout the study as detailed in the protocol.
• \. 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.

You may not qualify if:

• \. 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.
• \. Subjects who have a history of cardiac disease or arrhythmias that can cause QTc prolongation.
• \. Family history of long or short QT syndrome, hypokalaemia, syncope, or Torsades de Pointes.
• \. 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).
• \. 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.
• \. Previously having received MT-8554.
• \. 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.
• \. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Tympanic body temperature at Day -1 that is outside the local reference range, confirmed by repeat assessment.
• \. Subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (1)

Investigational center

City Name, United Kingdom

Location

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind, placebo controlled

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 20, 2018
• Study Start: April 23, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

GB (1)