Date: 2015-10-01
Type of information: Initiation of the trial
phase: 1
Announcement:
Company: Takeda Pharmaceutical (Japan)
Product: TAK-831
Action mechanism:
Disease: schizophrenia, cerebellar ataxia
Therapeutic area: CNS diseases - Mental diseases
Country: UK
Trial
details: TAK-831 is being tested to treat people who have schizophrenia and cerebellar ataxia. This study will look at the PK, safety and tolerability of TAK-831 in healthy participants. The study will enroll approximately 96 participants. The study will include 3 parts: Part 1 (single-rising dose [SRD]), Part 2 (SRD/multiple-rising dose [MRD]), and Part 3 (MRD). Participants will be randomly assigned (by chance, like flipping a coin) to receive either active drug TAK-831 or placebo which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): Dosing with TAK-831 will progress into study part 2 and 3, only after review of all available safety, tolerability, and PK data collected in Cohorts 1 to 2 of the Study Part 1 This single center trial will be conducted in the United Kingdom. The overall time to participate in this study is approximately up to 58 days. Participants will be admitted in the clinic for the up to 20 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment. (NCT02566759)
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