PK, PD, Safety & Tolerability AZD3043 JSAD bolus & JSAD bolus/infusion

• Research type

  Research Study

• Full title

  Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (age range 20-45 years).

• IRAS ID

  34515

• Contact name

  Ulrike Lorch

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2009-016262-85

• ISRCTN Number

  requested

• Research summary

  This study aims to assess the safety and tolerability of AZD3043 in healthy Japanese male and non-fertile female volunteers, and it will also investigate how the body handles this Investigational Medicinal Product (IMP) and how the volunteers are sedated or anaesthetised by it. 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 72 healthy Japanese volunteers aged 20 to 45 years. It follows on from a similar study in non-Japanese volunteers being conducted in Sweden. Since there are possible differences in how the IMP is handled by the body in different ethnic groups, the IMP must be assessed in Japanese volunteers before it can be given to Japanese patients. AZD3043 is the IMP that is being developed as a short-acting anaesthetic agent. Compared to the other similar anaesthetics, AZD3043 can work for a much shorter period of time as it is being broken down rapidly in the body. Therefore, AZD3043 is expected to give a faster and more controllable effect during sedation/anaesthesia. This study consists of two parts; Part A (up to 5 dose groups) and Part B (up to 4 dose groups) with 8 volunteers per group. Forty volunteers who participate in Part A will receive a one-off intravenous injection of AZD3043 only, whereas the other 32 volunteers who take part in Part B will be given an intravenous injection followed by a continuous infusion. After the IMP administration, volunteers will stay overnight in the clinical unit where safety assessments (e.g. blood pressure, blood and urine samples) will be performed. After the assessments on Day 2, volunteers will be allowed to leave the unit. They will return for a follow-up visit 6-11 days after the IMP administration.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0803/129

• Date of REC Opinion

  23 Nov 2009

• REC opinion

  Further Information Favourable Opinion