AZD Single Ascending Dose Study In Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD3043

• Registration Number: NCT01028040
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD3043	AZD3043	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the onset, level and recovery of/from sedation/anaesthesia.	Assessed on Day 1
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)

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom