A Phase I, Single-Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After Single Ascending Doses in Healthy Male Volunteers

AstraZeneca1 site in 1 country53 target enrollmentMay 2009

ConditionsHealthy

InterventionsAZD3043

DrugsAZD3043

Overview

Phase: Phase 1
Intervention: AZD3043
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 53
Locations: 1
Primary Endpoint: Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

August 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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)

Arms & Interventions

AZD3043

Intravenous solution

Intervention: AZD3043

Outcomes

Primary Outcomes

Assessment of Vital signs data, heart rate, electrocardiogram (ECG)

Time Frame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.

Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;

Time Frame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.

Secondary Outcomes

PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.(Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose.)
PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma(29 min, 45 min and 150 min post dose)