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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2009

Last Updated Date

December 8, 2010

Start Date ^ICMJE

December 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028040 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AZD Single Ascending Dose Study In Healthy Japanese Subjects

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: AZD3043
Intravenous, single dose
Drug: AZD3043
Infusion, single dose

Study Arm (s)

Experimental: AZD3043

Interventions:

Drug: AZD3043
Drug: AZD3043

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01028040

Other Study ID Numbers ^ICMJE

D0510C00004

Has Data Monitoring Committee

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dr. Ulrike Lorch, MFPM FRCA

Richmond Pharmacology Limited

Information Provided By

AstraZeneca

Verification Date

December 2010

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

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