| Eligibility |
Inclusion Criteria:
- 1. 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.
- 2. Caucasian male subjects aged 30 to 65 years (inclusive) at Screening.
- 3. Healthy and free from illness or disease as determined by medical history, physical
examination, electrocardiogram (ECG), vital signs, laboratory and other tests at
Screening and Day -1, unless deemed not clinically significant by the Investigator or
designee.
- 4. Body weight of 60 to 110 kg (inclusive) and a body mass index (Quetelet index)
ranging from 18 to 32 kg/m2 (inclusive) at Screening and Day -1.
- 5. Vital signs within the following ranges at Screening and Day -1:
- Systolic blood pressure: 90 to 140 mmHg
- Diastolic blood pressure: 50 to 90 mmHg
- 6. Subjects and partners agree to use contraception throughout the study, as defined
in the Protocol body.
- 7. Able to understand, in the Investigator's opinion, the nature of the study and any
risks involved in participation and willing to cooperate and comply with the Protocol
restrictions and requirements.
- 8. Regular daily bowel movements (i.e., production of at least one stool per day).
Exclusion Criteria:
- 1. Presence or history of severe adverse reaction or allergy to any medicinal product
that is of clinical significance.
- 2. Participated in more than three clinical studies of a new chemical entity in the
previous year or participated in a clinical study of any IMP within 12 weeks or five
half-lives (whichever is longer) before the administration of IMP in this clinical
study.
- 3. Consumption of any food-supplements, prescribed or over the counter medicine
(including herbal and dietary supplements, such as St. John's Wort) during the 7 days
(or 14 days if the medicine is a potential enzyme inducer) or five half-lives
(whichever is longer) before the administration of IMP and during the study, unless in
the opinion of the Sponsor and the Investigator, the medication will not interfere
with the objectives of the study or compromise the subject's safety (Note: The use of
acetaminophen [2 g/day for up to 3 consecutive days] will be permitted from Screening
and during the study).
- 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid,
hepatic (including Gilbert's syndrome), respiratory, gastrointestinal or renal
disease, diabetes mellitus (type I and II), coronary heart disease, hypertension, or
significant history of any psychiatric/psychotic 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. Subjects with aspartate aminotransferase or alanine aminotransferase =2 x upper
limit of normal or bilirubin above reference range at Screening or Day -1, confirmed
by a repeat test at each visit.
- 7. Has a positive hepatitis B surface antigen, hepatitis B core antibody, hepatitis C
virus antibody, or human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2)
result at Screening.
- 8. Clinically significant abnormal 12-lead ECG findings, including subjects with
corrected QT interval using Fridericia's formula (QTcF) of >450 ms, or presence of
atrial fibrillation or other significant arrhythmia at Screening or Day -1, confirmed
by repeat assessment.
- 9. 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 of participation in the study. The Investigator should be guided by evidence of
any of the following:
- history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or
rectal bleeding;
- history of major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy or bowel resection;
- history or clinical evidence of pancreatic injury or pancreatitis.
- 10. Excessive consumption of food or drink containing caffeine, including coffee, tea,
cola, energy drinks or chocolates (>5 cups of coffee or equivalent per day).
- 11. Consumption of food or drink containing grapefruit, poppy seeds or Seville oranges
from 7 days before the administration of the IMP.
- 12. Presence or history (in the last 2 years) of alcohol abuse or weekly alcohol
intake of more than 28 units (224 g) or a positive urine or breath alcohol test at
Screening or Day 1. One unit (8 g) is equivalent to a ½ pint (280 mL) of beer, 1
measure (25 mL) of spirits or 1 small glass (125 mL) of wine.
- 13. 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.
- 14. Donation of one or more units of blood (450 mL) within 3 months before the
administration of the IMP, or plasma within 7 days prior to Screening, or platelets
within 6 weeks prior to Screening or the intention to donate blood within 3 months
after the final study visit.
- 15. Use of tobacco or nicotine-containing products (snuff, chewing tobacco, cigars,
pipes, e cigarettes or nicotine replacement products) within the 3 month period prior
to administration of IMP, during the confinement period and until the final study
visit, or positive urine cotinine test at Screening or Day -1.
- 16. Heavy physical training or excessive exercise (e.g., long distance running, weight
lifting or any physical activity to which the subject is not accustomed) from 7 days
before the administration of IMP, during the participation in the study and for 7 days
prior to any outpatient visit.
- 17. Family history of long QT syndrome or Torsades de Pointes.
- 18. Subjects with poor peripheral venous access.
- 19. Subjects who had a major surgical procedure or significant traumatic injury within
14 days prior to Day -1, or anticipation of the need for major surgery during the
study period.
- 20. Subjects with creatinine clearance <60 mL/minute (calculated using Cockcroft-Gault
formula) at Screening.
- 21. History of irritable bowel syndrome or other manifestation of abnormal bowel habit
(e.g., diarrhoea, constipation).
- 22. Previous exposure to MT-7117 before the administration of IMP in this study.
- 23. Radiation exposure, including that from the present study, excluding background
radiation but including diagnostic x rays and other medical exposures, exceeding 5 mSv
in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
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