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

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Sedation; Tolerability; Pharmacokinetics; Safety

Treatments: Drug: AZD3043

Study type: Interventional

Funder types: Industry

Identifiers

NCT01086813

AZD3043

D0510C00005

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD3043