Safety, Tolerability & PK of TAK-831 as SAD & MAD in Healthy Subjects

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-831 in Healthy Subjects.

• IRAS ID

  185930

• Eudract number

  2015-002295-24

• Duration of Study in the UK

  0 years, 9 months, 8 days

• Research summary

  This is a phase 1, double-blind, placebo-controlled clinical study in healthy male and female volunteers to assess the safety, tolerability and pharmacokinetics of TAK-831. The study is divided into 3 parts (Parts 1, 2, and 3). Separate groups of participants will be included in each part of the study.

  This is the first time TAK-831 will be given to human participants and is a First in Human (FiH) study. The study will recruit healthy, non-smoking, males and females (of non-childbearing potential) between the ages of 18 and 55 years. Approximately 96 volunteers will take part in the study.

  The new medicine tested in this study is called TAK-831. Takeda is developing the study drug for treating schizophrenia as well as cerebellar ataxia.

  Schizophrenia is a mental health condition causing a wide range of symptoms, such as hallucinations (seeing things that do not exist), delusions (unusual beliefs not based on reality), mixed up thoughts based on hallucinations or delusions, and changes in behavior.

  Ataxia is a medical term used to describe disorders that affect coordination, balance and speech. Cerebellar ataxia is a form of ataxia that is caused by damage to the cerebellum, part of the brain responsible for movement and coordination. Patients with cerebellar ataxia may have difficulties with walking, speaking, swallowing, writing, eating and walking.

  The main purpose of the study is to see how safe the study drug is and how well it is tolerated after single and multiple doses. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). A further aim is to look at the amount of D-serine and L-serine (molecules in the brain) in the blood and cerebrospinal fluid (liquid in the spine).

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0412

• Date of REC Opinion

  4 Sep 2015

• REC opinion

  Further Information Favourable Opinion