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

This study has been withdrawn prior to enrollment.
(The compound is being re-evaluated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01086813
First received: March 9, 2010
Last updated: December 19, 2012
Last verified: December 2012

March 9, 2010
December 19, 2012
March 2010
April 2010   (final data collection date for primary outcome measure)
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043 [ Time Frame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session ] [ Designated as safety issue: Yes ]
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043 in elderly (=65 years) healthy subjects. [ Time Frame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01086813 on ClinicalTrials.gov Archive Site
  • To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples [ Time Frame: During 24h ] [ Designated as safety issue: Yes ]
  • To evaluate the onset, level and recovery from sedation/anaesthesia [ Time Frame: During 24h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 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

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Sedation
Drug: AZD3043
single dose/IV, bolus over 60secs - infusion over 30 mins
Experimental: 1
Intervention: Drug: AZD3043
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
65 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01086813
D0510C00005, AZD3043
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP