Mass Balance Study of MT-1303

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total radioactivity in urine and faeces	up to 10 weeks

Secondary Outcome Measures

Name	Time	Method
PK of total radioactivity in plasma	up to 10 weeks

Recruitment & Eligibility