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

NCT ID: NCT01086813

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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

Conditions

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Safety Tolerability Pharmacokinetics Sedation

Keywords

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Safety Tolerability Pharmacokinetics Sedation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD3043

Intervention Type DRUG

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

Interventions

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AZD3043

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Darren Wilbraham

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited Kingdom

Stephen Kanes

Role: STUDY_DIRECTOR

AstraZeneca

Brendan Smyth

Role: STUDY_CHAIR

AstraZeneca

Other Identifiers

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AZD3043

Identifier Type: -

Identifier Source: secondary_id

D0510C00005

Identifier Type: -

Identifier Source: org_study_id