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

Sponsor

AstraZeneca (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01086813

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Safety Tolerability Pharmacokinetics Sedation	Drug: AZD3043	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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 Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Apr 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD3043

single dose/IV, bolus over 60secs - infusion over 30 mins

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Darren Wilbraham, Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited Kingdom
Study Director: Stephen Kanes, AstraZeneca
Study Chair: Brendan Smyth, AstraZeneca