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

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ClinicalTrials.gov Identifier: NCT00918515
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : August 28, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD3043 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: AZD3043
Intravenous solution
Drug: AZD3043
intravenous solution given once as intravenous infusion over 30 minutes

Primary Outcome Measures :
  1. 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. ]
  2. 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 Outcome Measures :
  1. 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. ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918515

Research Site
Stockholm, Sweden
Sponsors and Collaborators
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

Responsible Party: Stephen Kanes, Medical Science Director, AstraZeneca Pharmaceuticals US
ClinicalTrials.gov Identifier: NCT00918515     History of Changes
Other Study ID Numbers: D0510C00001
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009

Keywords provided by AstraZeneca:
healthy male volunteers