AZD Single Ascending Dose Study In Healthy Japanese Subjects - Full Text View

Purpose

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	Intervention	Phase
Healthy	Drug: AZD3043	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	72
Study Start Date:	December 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD3043	Drug: AZD3043 Intravenous, single dose Drug: AZD3043 Infusion, single dose

Eligibility


Ages Eligible for Study:	20 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01028040 History of Changes
Other Study ID Numbers:	D0510C00004
Study First Received:	December 8, 2009
Last Updated:	December 8, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:


Phase I AZD3043 Japanese healthy volunteer

ClinicalTrials.gov processed this record on September 29, 2016

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