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.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Amiselimod
What it measured
Main measures
Total radioactivity in urine and faeces
up to 10 weeks
Other measures (1)
PK of total radioactivity in plasma
up to 10 weeks
How the body handles the medicine
Who could take part
Relapsing MS · 30 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.
Papers
Loading reviews and guidelines…
Related trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Phase 3 · Not yet recruiting
Still running
- Study to Assess Effects of Ublituximab in Pediatric Participants With
Phase 2 / Phase 3 · Recruiting
Still running
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to
Phase 3 · Recruiting
Still running
- Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozani
Phase 4 · Recruiting
Still running
- Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarker
Phase 4 · Withdrawn
Stopped
- A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese
Phase 4 · Running, not recruiting
Still running
History
Started
Sept 2014
Main results due
Dec 2014
Finished
Dec 2014