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

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ClinicalTrials.gov Identifier: NCT01086813
Recruitment Status : Withdrawn (The compound is being re-evaluated)
First Posted : March 15, 2010
Last Update Posted : December 20, 2012
Sponsor:
Information provided by:
AstraZeneca

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 Type : Interventional  (Clinical Trial)
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 : March 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples [ Time Frame: During 24h ]
  2. To evaluate the onset, level and recovery from sedation/anaesthesia [ Time Frame: During 24h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086813


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01086813     History of Changes
Other Study ID Numbers: D0510C00005
AZD3043
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by AstraZeneca:
Safety
Tolerability
Pharmacokinetics
Sedation