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

NCT ID: NCT00984880

Last Updated: 2009-12-18

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).

Detailed Description

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Conditions

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Healthy

Keywords

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Sedation anaesthesia Safety Tolerability Pharmacokinetics Pharmacodynamics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intravenous solution given as a single ascending bolus dose

Group Type EXPERIMENTAL

AZD3043

Intervention Type DRUG

Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

2

Intravenous solution given as a single ascending bolus dose followed by a single infusion

Group Type EXPERIMENTAL

AZD3043

Intervention Type DRUG

Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

Interventions

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AZD3043

Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with suitable veins for cannulation or repeated venepuncture
* Pre-dose assessment judged without remarks by the investigator
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

* Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
* Systolic blood pressure \>140 mm Hg
* Diastolic blood pressure \>90 mm Hg
* Heart rate ≤45 or \>85 beats per minute
* Lack of normal phenotype for BuChE (Butyrylcholinesterase)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Johan Wemer

Role: STUDY_CHAIR

AstraZeneca

Sigridur Kalman

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Stephen Kanes

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Norberg A, Koch P, Kanes SJ, Bjornsson MA, Barassin S, Ahlen K, Kalman S. A Bolus and Bolus Followed by Infusion Study of AZD3043, an Investigational Intravenous Drug for Sedation and Anesthesia: Safety and Pharmacodynamics in Healthy Male and Female Volunteers. Anesth Analg. 2015 Oct;121(4):894-903. doi: 10.1213/ANE.0000000000000804.

Reference Type DERIVED
PMID: 26097986 (View on PubMed)

Other Identifiers

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Eudract number: 2008-005836-34

Identifier Type: -

Identifier Source: secondary_id

D0510C00002

Identifier Type: -

Identifier Source: org_study_id