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

NCT ID: NCT00918515

Last Updated: 2009-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Sedation Anaesthesia Safety tolerability pharmacokinetics pharmacodynamics healthy male volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD3043

Intravenous solution

Group Type EXPERIMENTAL

AZD3043

Intervention Type DRUG

intravenous solution given once as intravenous infusion over 30 minutes

Interventions

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AZD3043

intravenous solution given once as intravenous infusion over 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals US

Principal Investigators

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Johan Wemer

Role: STUDY_CHAIR

AstraZeneca R&D Södertälje

Sigridur Kalman

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2007-003474-26

Identifier Type: -

Identifier Source: secondary_id

D0510C00001

Identifier Type: -

Identifier Source: org_study_id