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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: AZD3043 | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: AZD3043 |
Drug: AZD3043
Intravenous, single dose
Drug: AZD3043
Infusion, single dose
|
- 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) ]
- 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) ]
- To evaluate the onset, level and recovery of/from sedation/anaesthesia. [ Time Frame: Assessed on Day 1 ]

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

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
United Kingdom | |
Research Site | |
London, United Kingdom |
Principal Investigator: | Dr. Ulrike Lorch, MFPM FRCA | Richmond Pharmacology Limited |
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 |