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

Pharmacokinetics Clinical Trial

— AZD3043  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01086813
• Other study ID #: D0510C00005
• Secondary ID: AZD3043
• Status: Withdrawn
• Phase: Phase 1
• First received: March 9, 2010
• Last updated: December 19, 2012
• Start date: March 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics
• Safety
• Sedation
• Tolerability

Intervention

Drug:
• AZD3043
single dose/IV, bolus over 60secs - infusion over 30 mins

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples		During 24h	Yes
Secondary	To evaluate the onset, level and recovery from sedation/anaesthesia		During 24h	Yes