Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD3043

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984880

D0510C00002

Eudract number: 2008-005836-34

Details and patient eligibility

About

The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with suitable veins for cannulation or repeated venepuncture
• Pre-dose assessment judged without remarks by the investigator
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

• Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
• Systolic blood pressure >140 mm Hg
• Diastolic blood pressure >90 mm Hg
• Heart rate ≤45 or >85 beats per minute
• Lack of normal phenotype for BuChE (Butyrylcholinesterase)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1

Experimental group

Description:

Intravenous solution given as a single ascending bolus dose

Treatment:

Drug: AZD3043

2

Experimental group

Description:

Intravenous solution given as a single ascending bolus dose followed by a single infusion

Treatment:

Drug: AZD3043