AZD Single Ascending Dose Study In Healthy Japanese Subjects

NCT01028040 | Completed Phase 1

• 1 other identifier: D0510C00004
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase I; AZD3043; Japanese healthy volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

AZD3043

EXPERIMENTAL

Drug: AZD3043

Interventions

AZD3043 DRUG

Intravenous, single dose

AZD3043

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

AZD-3043

Study Officials

• Dr. Ulrike Lorch, MFPM FRCA

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

GB (1)