Mass Balance Study With MT-7117

NCT03503266 | Completed Phase 1

• 2 other identifiers: MT-7117-E022017-004549-25
• 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 7117.

Conditions

Healthy Volunteer

Keywords

Mass Balance Study with MT-7117

Outcome Measures

Primary Outcomes (10)

• Cmax - maximum observed plasma concentration (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• tmax - time at which Cmax occurs (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• AUC0 t - area under the plasma concentration time curve from time zero to the last measurable concentration (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• t½ - apparent terminal elimination half-life (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• Kel - terminal elimination rate constant (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• CL/F - apparent clearance (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• VZ/F - apparent volume of distribution (plasma and whole blood)

  at pre-dose and up to 168 hours post-dose. If collection is extended up to Day 14: at up to 312 hours post-dose.

• Total radioactivity in urine and faeces

  Ae (urine), Ae (faeces) and Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined).

  Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.

• Total radioactivity in urine and faeces

  %Ae (urine), %Ae (faeces) and %Ae (total): amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the dose.

  Day -1 and up to 168 hours post-dose. If collection is extended up to Day 14: up to 312 hours post-dose.

Secondary Outcomes (1)

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

  Up to 14 Days after dosing

Study Arms (1)

[14C] MT-7117

EXPERIMENTAL

14-C MT-7117

Drug: [14C] MT-7117

Interventions

[14C] MT-7117 DRUG

14-C MT-7117

[14C] MT-7117

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• \. Caucasian male subjects aged 30 to 65 years (inclusive) at Screening.
• \. 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.
• \. 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.
• \. 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
• \. Subjects and partners agree to use contraception throughout the study, as defined in the Protocol body.
• \. 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.
• \. Regular daily bowel movements (i.e., production of at least one stool per day).

You may not qualify if:

• \. Presence or history of severe adverse reaction or allergy to any medicinal product that is of clinical significance.
• \. 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.
• \. 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).
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Excessive consumption of food or drink containing caffeine, including coffee, tea, cola, energy drinks or chocolates (\>5 cups of coffee or equivalent per day).
• \. Consumption of food or drink containing grapefruit, poppy seeds or Seville oranges from 7 days before the administration of the IMP.
• \. 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.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (1)

Investigational Centre

United Kingdom, United Kingdom

Location

Related Publications (1)

• Ogasawara A, Ide R, Inoue S, Tsuda M, Teng R. Assessment of Potential Drug-Drug Interactions for Novel Oral Melanocortin-1 Receptor Agonist Dersimelagon. Pharmacol Res Perspect. 2025 Feb;13(1):e70069. doi: 10.1002/prp2.70069.

  PMID: 39887900 DERIVED

Study Officials

• General Manager

  Mitsubishi Tanabe Pharma Europe Ltd

  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: March 18, 2018
• First Posted: April 19, 2018
• Study Start: March 23, 2018
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

GB (1)