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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Safety
Tolerability
Pharmacokinetics
Sedation
Drug: AZD3043
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD3043
single dose/IV, bolus over 60secs - infusion over 30 mins

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

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01086813     History of Changes
Other Study ID Numbers: D0510C00005, AZD3043
Study First Received: March 9, 2010
Last Updated: December 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
Tolerability
Pharmacokinetics
Sedation

ClinicalTrials.gov processed this record on April 17, 2014