Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043 (AZD3043)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Pharmacokinetics; Sedation; Tolerability; Safety
• Intervention / Treatment: Drug: AZD3043

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

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD3043; single dose/IV, bolus over 60secs - infusion over 30 mins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Darren Wilbraham, Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited Kingdom

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 12, 2010
• First Posted (Estimate): March 15, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Sedation; Tolerability
• Other Study ID Numbers: D0510C00005; AZD3043