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Completed

NCT Number: NCT00918515

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD3043

Drug

intravenous solution given once as intravenous infusion over 30 minutes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Jun 11, 2009
Registry last updated
Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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