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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD3043; Drug: AZD3043

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AZD3043	Drug: AZD3043; Intravenous, single dose; Drug: AZD3043; Infusion, single dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK	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.	Assessed on Day 1

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dr. Ulrike Lorch, MFPM FRCA, Richmond Pharmacology Limited

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (ESTIMATE): December 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Phase I; Japanese healthy volunteer; AZD3043
• Other Study ID Numbers: D0510C00004