Mass Balance Study of MT-1303

NCT ID: NCT02293967

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.

Conditions

Relapsing-remitting Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MT-1303

\[14C\] MT-1303 after a single oral dose

Group Type: EXPERIMENTAL

MT-1303

Intervention Type: DRUG

Interventions

MT-1303

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Caucasian male aged 30 to 65 at Screening.
• Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
• Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
• Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
• Regular daily bowel movements.

Exclusion Criteria

• 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.
• Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
• 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:

• history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
• history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pui Leung

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Locations

Investigational site

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

References

Kifuji T, Inoue S, Furukawa M, Perez Madera B, Goto T, Kumagai H, Mair SJ, Kawaguchi A. Absorption, disposition and metabolic pathway of amiselimod (MT-1303) in healthy volunteers in a mass balance study. Xenobiotica. 2019 Sep;49(9):1033-1043. doi: 10.1080/00498254.2018.1525508. Epub 2018 Dec 21.

Reference Type: DERIVED

PMID: 30231665 (View on PubMed)

Other Identifiers

MT-1303-E11

Identifier Type: -

Identifier Source: org_study_id