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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD3043

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AZD3043; Intravenous solution	Drug: AZD3043; intravenous solution given once as intravenous infusion over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Johan Wemer, AstraZeneca R&D Södertälje; Principal Investigator: Sigridur Kalman, Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (ESTIMATE): June 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2009
• Last Update Submitted That Met QC Criteria: August 27, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Safety; tolerability; pharmacokinetics; Sedation; pharmacodynamics; Anaesthesia; healthy male volunteers
• Other Study ID Numbers: D0510C00001; 2007-003474-26