NCT01086813

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

1 month

First QC Date

March 9, 2010

Last Update Submit

December 19, 2012

Conditions

SafetyTolerabilityPharmacokineticsSedation

Keywords

SafetyTolerabilityPharmacokineticsSedation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD3043

Interventions

AZD3043DRUG

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

1

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AZD-3043

Study Officials

  • Darren Wilbraham

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

    PRINCIPAL INVESTIGATOR

  • Stephen Kanes

    AstraZeneca

    STUDY DIRECTOR

  • Brendan Smyth

    AstraZeneca

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 15, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 20, 2012

Record last verified: 2012-12