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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01086813

Acronym

AZD3043

Enrollment

Registered

2010-03-15

Start date

2010-03-31

Completion date

2010-04-30

Last updated

2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Safety, Sedation, Tolerability

Keywords

Safety, Tolerability, Pharmacokinetics, Sedation

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

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

Interventions

DRUGAZD3043

single dose/IV, bolus over 60secs - infusion over 30 mins

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026