Safety, Tolerability and PK of Single and Multiple Doses of MT-6345

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MT-6345 in Healthy Subjects; Including Investigation of the Effect of Food, Gender and Race on the Pharmacokinetics of a Single Dose of MT-6345 in Healthy Subjects

• IRAS ID

  251464

• Contact name

  Robert K. Hofbauer

• Sponsor organisation

  Mitsubishi Tanabe Pharma Development America Inc.

• Eudract number

  2018-002478-39

• Duration of Study in the UK

  0 years, 8 months, 5 days

• Research summary

  The Sponsor is developing the test medicine MT-6345 for the treatment of binge eating disorder (BED). BED is a serious mental illness where people experience a loss of control and eat large quantities of food all at once until they feel uncomfortably full, and then often upset or guilty. BED can affect anyone of any age, gender, or background

  The study will investigate the pharmacokinetics (PK) of MT-6345 (how the test medicine is taken up by the body) following single and multiple oral doses in healthy Caucasian male volunteers. The effect of food, gender and race will also be investigated.

  The study will consist of 5 parts. In Part 1, up to 56 healthy Caucasian male volunteers will receive a single dose of the test medicine or placebo (dummy medicine) in the fasted state. In Part 2, a single cohort of volunteers from Part 1 will receive a repeat single dose of the test medicine or placebo, in the fed state. In Part 3 up to 48 healthy Caucasian male volunteers will receive multiple doses of the test medicine or placebo in the fasted state. In Part 4, 8 healthy Caucasian female volunteers will receive a single dose of the test medicine or placebo in the fasted state. In Part 5, 8 healthy Japanese male volunteers will receive a single dose of the test medicine or placebo in the fasted state.

  For single dose cohorts, volunteers will remain in the clinical unit for 48 h post-dose; the Japanese cohort will remain for 120 h post-dose. For multiple dose cohorts, volunteers will remain in the clinical unit for a minimum of 17 days post-first dose; depending on the observed half-life of the test medicine MT-6345 as the study progresses, this period may be extended to up to 31 days post-first dose.

• REC name

  HSC REC A

• REC reference

  18/NI/0209

• Date of REC Opinion

  21 Dec 2018

• REC opinion

  Further Information Favourable Opinion