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CompletedNCT00918515Updated Aug 28, 2009

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

A Phase 1 interventional study of AZD3043 in Healthy, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-28.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Sedation
  • Anaesthesia
  • Safety
  • tolerability
  • pharmacokinetics
  • pharmacodynamics
  • healthy male volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    AZD3043

    Intravenous solution

    Drug: AZD3043

Interventions

  • DrugAZD3043

    intravenous solution given once as intravenous infusion over 30 minutes

06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    Stockholm, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00918515
Lead sponsor
AstraZeneca
First posted
Jun 11, 2009
Start date
May 2009
Completion
Aug 2009
Last update
Aug 28, 2009

Study contacts

Johan Wemer
study chair · AstraZeneca R&D Södertälje
Sigridur Kalman
principal investigator · Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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