Mass Balance Study With MT-8554

NCT03381404 | Completed Phase 1

• 2 other identifiers: MT-8554-E072017-002830-21
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of \[14C\] MT 8554.

Conditions

Healthy Volunteer

Keywords

Mass Balance Study with MT-8554

Outcome Measures

Primary Outcomes (6)

• Total radioactivity in urine and faeces

  Up to 14 Days after dosing

• Maximum observed plasma concentration [Cmax]

  Up to 14 Days after dosing

• Time at which Cmax occurs [tmax]

  Up to 14 Days after dosing

• Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-last]

  Up to 14 Days after dosing

• Apparent terminal elimination half-life [t1/2]

  Up to 14 Days after dosing

• Terminal elimination rate constant [Kel]

  Up to 14 Days after dosing

Secondary Outcomes (2)

• Safety and tolerability as measured by adverse events (AEs)

  Up to 14 Days after dosing

• Safety and tolerability as measured by vital signs

  Up to 14 Days after dosing

Study Arms (1)

[14C] MT-8554

EXPERIMENTAL

Drug: [14C] MT-8554

Interventions

[14C] MT-8554 DRUG

14-C MT-8554

[14C] MT-8554

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Able to provide written informed consent to participate in this study after reading the participant information sheet and informed consent form and after having the opportunity to discuss the study with the Investigator or designee.
• \. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening and Day 1.
• \. Male Caucasian subjects, aged 30 to 55 years (inclusive) at Screening.
• \. A body weight of ≥60 kg and a body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive) at Screening or Day 1.
• \. Subjects and partners agree to use contraception throughout the study as detailed in the Protocol body.
• \. 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.
• \. Regular daily bowel movements (i.e., production of at least one stool per day).

You may not qualify if:

• \. Previously having received MT-8554.
• \. Participation in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks (or, if relevant, five half-lives, whichever is the longer) prior to dosing.
• \. 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, five half-lives, whichever is longer) prior to dosing 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, five half-lives, whichever is longer) prior to dosing will also be excluded unless, in the opinion of the Investigator or 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 dosing unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety. Occasional use (2 g/day for 3 days) 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, five half-lives, whichever is longer) prior to dosing unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
• \. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal, renal, 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 compromise subject safety, as judged by the Investigator.
• \. Subjects with aspartate aminotransferase, alanine aminotransferase ≥1.5 × upper limit of normal or total bilirubin or creatine kinase above the reference range at Screening or Day 1.
• \. Subjects with creatinine clearance \<60 mL/min (calculated using the Cockcroft-Gault-formula) at Screening.
• \. Family history of long or short QT syndrome, syncope of unknown cause or Torsades de Pointes.
• \. Clinically significant 12-lead electrocardiogram (ECG) abnormalities, including subjects with corrected QT interval using Fridericia's formula (QTcF) of \>450 ms, at Screening or Day 1, confirmed by repeat assessment.
• \. Blood pressure (supine) at Screening or Day 1 outside the range of 90 to 140 mmHg (systolic) or 50 to 90 mmHg (diastolic) and pulse rate outside the range of 40 to 100 beats per minute, confirmed by repeat assessment. Evidence of postural hypotension at Screening defined as a decrease of \>20 mmHg in systolic or \>10 mmHg in diastolic blood pressure between the supine and standing position, confirmed by repeat assessment.
• \. Tympanic body temperature at Day 1 that is outside the local reference range (35.5°C to 37.8°C), confirmed by repeat assessment.
• \. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks or chocolates (≥5 cups of coffee or equivalent per day).

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 22, 2017
• Study Start: December 19, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

GB (1)