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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01028040
First received: December 8, 2009
Last updated: December 8, 2010
Last verified: December 2010

December 8, 2009
December 8, 2010
December 2009
August 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028040 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • To evaluate the onset, level and recovery of/from sedation/anaesthesia. [ Time Frame: Assessed on Day 1 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • To evaluate the onset, level and recovery of/from sedation/anaesthesia. [ Time Frame: Assessed on Day 1 ]
Not Provided
Not Provided
 
AZD Single Ascending Dose Study In Healthy Japanese Subjects
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: AZD3043
    Intravenous, single dose
  • Drug: AZD3043
    Infusion, single dose
Experimental: AZD3043
Interventions:
  • Drug: AZD3043
  • Drug: AZD3043
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01028040
D0510C00004
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Dr. Ulrike Lorch, MFPM FRCA Richmond Pharmacology Limited
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP