MedDataX Logo

Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

NCT ID: NCT00738959

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

AZD0328 Japanese Caucasian pharmacokinetics safety tolerability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

AZD0328

Intervention Type DRUG

Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD0328

Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

Exclusion Criteria

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
* Participation in another study within 12 weeks before the first administration of the investigational product.
* Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca R&D, Södertälje, Sweden

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Didier Meulien, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje, Sweden

Ulrike Lorch, MD

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUdract NO 2008-001723-56

Identifier Type: -

Identifier Source: secondary_id

D0190C00008

Identifier Type: -

Identifier Source: org_study_id