Safety, tolerability, PK AZD7687 SAD and MAD in Japanese Males

• Research type

  Research Study

• Full title

  A Phase 1, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of oral AZD7687 after Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects

• IRAS ID

  63486

• Contact name

  Ulrike Lorch

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2010-022575-55

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to assess the safety and tolerability of AZD7687 in healthy Japanese male volunteers, and it will also investigate how the body handles AZD7687. This study has been designed and sponsored by AstraZeneca (AZ) and will be conducted by Richmond Pharmacology Limited (RPL).This study will involve up to 36 healthy Japanese volunteers aged 20 to 45 years. It follows on from separate, but similar single dose and multiple dose studies in non-Japanese volunteers. Since there are possible differences in how AZD7687 is handled by the body in different ethnic groups, therefore AZD7687 must be assessed in Japanese volunteers before it can be given to Japanese patients. This is the first time this drug will be given to Japanese people.AZD7687 is an investigational new drug that's being developed for the treatment of obesity and type 2 diabetes. It has been shown in in vivo studies that inhibiting DGAT1 (a protein that's important in lipid storage) could have beneficial effects on glucose metabolism in type 2 diabetes. AZD7687 is a selective inhibitor of DGAT1 and is expected to be able to deliver weight loss through reduction of food intake. AZD7687 is not available by prescription or over the counter medication but is under research in clinical trials. Volunteers will be given AZD7687 or placebo (dummy drug) on Day 1 and Days 3-9 once or twice daily. The twice daily dosing will be determined from the results of previous studies. AZD7687 will be given to the volunteer by mouth as an oral solution. They will leave the Unit on Day 11 and return for a safety follow-up visit 7-14 days after the last dose. Volunteers are required to be resident in the Unit for 12 days/11 nights. Each volunteer will participate for approximately eight weeks.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/27

• Date of REC Opinion

  8 Nov 2010

• REC opinion

  Further Information Favourable Opinion