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Safety, Tolerability & PK of MR1916 plus a FE part in healthy subjects

  • Research type

    Research Study

  • Full title

    A first-in-human, randomized, double blind, placebo controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics, and a crossover study to investigate the food-effect of MR1916 in healthy subjects

  • IRAS ID

    163703

  • Contact name

    Takaaki Negishi

  • Contact email

    tnegishi@mochida.co.jp

  • Sponsor organisation

    Mochida Pharmaceutical Co.,Ltd.

  • Eudract number

    2014-004139-37

  • Duration of Study in the UK

    0 years, 9 months, 8 days

  • Research summary

    The new medicine tested in this study is a compound called MR1916. The Sponsor is developing the study drug for treating schizophrenia.

    This study will be divded into study part A and study part B. The study will recruit healthy, non smoking, men between the ages of 18 and 55 years (inclusive). There will be a total of 62 subjects included in this study (Part A and Part B).

    The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. The study will also try to determine the effects that the study drug may have on the electrical activity of the brain, this will be done by performing electroencephalograms (EEGs) during the study. In Part B a further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.

    Vital signs, safety ECG measurements, safety laboratory assessments, adverse events , concomitant medications, scheduled physical and neurological examinations will be monitored throughout the entire investigational period.
    Prolactin tests (a hormone produced in the pituitary gland) , Extrapyramidal Symptoms Rating Scale-Abbreviated (to evaluate if the study drug effects movement), Bond and Lader Visual Analogue Scales (questionnaire to assess mood and alertness) , Stanford Sleepiness Scale (questionnaire used to assess alertness to sleepiness) and Columbia-Suicide Severity Rating Scale (C-SSRS) (evaluate the degree of suicidal ideation and thoughts) will be performed . Blood and urine samples for pharmacokinetic analysis will be collected. For Part A electroencephalograms (EEG) to detect the electrical activity of the brain and event related potentials will be recorded. In Part B Blood samples for metabolic profiling will be collected.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    14/LO/2023

  • Date of REC Opinion

    13 Jan 2015

  • REC opinion

    Further Information Favourable Opinion