Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
- Registration Number
- NCT01086813
- Lead Sponsor
- AstraZeneca
- Brief Summary
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers
- Detailed Description
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Pre-anaesthesia assessment judged without remarks by the investigator.
- ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)
Exclusion Criteria
- Lack of a normal range of enzyme activity for BuChE
- Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
- Prolonged QTcF >450 ms or shortened QTcF <350 ms or family history of long QT syndrome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD3043 -
- Primary Outcome Measures
Name Time Method To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043 Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session
- Secondary Outcome Measures
Name Time Method To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples During 24h To evaluate the onset, level and recovery from sedation/anaesthesia During 24h