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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD3043

• Registration Number: NCT00918515
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Status Verified: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-27
• Last Update Posted: 2009-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD3043	AZD3043	Intravenous solution

Primary Outcome Measures

Name	Time	Method
Assessment of Vital signs data, heart rate, electrocardiogram (ECG)	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;	The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden