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AZD Single Ascending Dose Study In Healthy Japanese Subjects (JSAD)

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ClinicalTrials.gov Identifier: NCT01028040
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase I, Single Centre, Open Label Study to Access The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (Age Range 20-45 Years)
Study Start Date : December 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD3043 Drug: AZD3043
Intravenous, single dose
Drug: AZD3043
Infusion, single dose


Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B). [ Time Frame: From screening period to follow-up visit 42 days (Maximum) ]

Secondary Outcome Measures :
  1. To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK [ Time Frame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) ]
  2. To evaluate the onset, level and recovery of/from sedation/anaesthesia. [ Time Frame: Assessed on Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture.
  • Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
  • Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
Contacts and Locations
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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): NCT01028040


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr. Ulrike Lorch, MFPM FRCA Richmond Pharmacology Limited
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01028040     History of Changes
Other Study ID Numbers: D0510C00004
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Phase I
AZD3043
Japanese healthy volunteer