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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014