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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918515
• Other study ID #: D0510C00001
• Secondary ID: 2007-003474-26
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2009
• Last updated: August 27, 2009
• Start date: May 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD3043
intravenous solution given once as intravenous infusion over 30 minutes

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Secondary	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.	No
Secondary	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	No