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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AZD3043

Study type

Interventional

Funder types

Industry

Identifiers

NCT00918515

2007-003474-26

D0510C00001

Details and patient eligibility

About

This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.

Enrollment

53 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
Pre-dose assessment judged without remarks by the investigator
Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg

Exclusion criteria

After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
Systolic blood pressure (BP) >140 mm Hg.·
Diastolic BP >90 mm Hg.
Heart rate <=55 or >85 beats per minute
Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference > 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
Lack of a normal phenotype for butyrylcholinesterase (pseudo-cholinesterase)