Mass Balance Study of MT-1303

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02293967

Enrollment

Registered

2014-11-19

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting Multiple Sclerosis

Brief summary

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

Interventions

DRUGMT-1303

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Total radioactivity in urine and faeces	up to 10 weeks

Secondary

Measure	Time frame
PK of total radioactivity in plasma	up to 10 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026