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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00918515
First received: June 9, 2009
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD3043
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma. [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma [ Time Frame: 29 min, 45 min and 150 min post dose ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: May 2009
Study Completion Date: August 2009
Arms Assigned Interventions
Experimental: AZD3043
Intravenous solution
Drug: AZD3043
intravenous solution given once as intravenous infusion over 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918515

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Stephen Kanes, Medical Science Director, AstraZeneca Pharmaceuticals US
ClinicalTrials.gov Identifier: NCT00918515     History of Changes
Other Study ID Numbers: D0510C00001, 2007-003474-26
Study First Received: June 9, 2009
Last Updated: August 27, 2009
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Sedation
Anaesthesia
Safety
tolerability
pharmacokinetics
pharmacodynamics
healthy male volunteers

ClinicalTrials.gov processed this record on July 22, 2014