Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers

July 12, 2012 updated by: AstraZeneca

A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers

The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active metabolite, safety, tolerability of AZD6140 following single administration in healthy male Japanese volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject aged between 20 to 45 years inclusive
  • Body mass index (BMI=weight/height2) between 18.0 to 27.0 kg/m2 inclusive
  • Body weight between 50.0 to 85.0 kg inclusive Provision of written informed consent

Exclusion Criteria:

  • Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator, or positive results on screening tests for serum hepatitis B surface antigen and hepatitis C antibody, syphilis and human immu
  • Supine blood pressure > 150 mmHg systolic or > 95 mmHg diastolic or supine pulse > 90 beats per minute (after resting for 10 minutes) Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
  • Personal or familial predisposition for thrombotic disorders Clinically significant medical history, including psychiatric disorders and severe allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZD6140
single administration of 90 mg dose of AZD6140
Drug: AZD6140
tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Description of pharmacokinetics for AZD6140 in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC and Cmax ratios of AR-C124910XX to AZD6140, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers.
Time Frame: From day 1 (pre-dose) till Day 4 (72h)
Maximum Concentration (Cmax), Time to reach maximum (peak) plasma concentration (tmax), Terminal plasma half-life (t½), Area under the plasma concentration-time curve from time zero to time t (AUC(0-t)),Area under the plasma concentration-time curve (AUC), Apparent total clearance of the drug from plasma after oral administration (CL/F), Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F), Mean residence time (MRT), and AUC and Cmax ratios of AR-C124910XX to AZD6140,
From day 1 (pre-dose) till Day 4 (72h)
Description of pharmacokinetics profile for AR-C124910XX, which is AZD6140 active metabolite, in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers.
Time Frame: From day 1 (pre-dose) till Day 4 (72h)
From day 1 (pre-dose) till Day 4 (72h)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
AZD6140 Safety and tolerability profile in terms of: adverse events, vital signs (blood pressure and pulse rate), electrocardiograms (ECGs), laboratory variables
Time Frame: From Day -1 (pre-dose) up to 7-10 days after dose
From Day -1 (pre-dose) up to 7-10 days after dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hidenori Komori, MD PHD, AstraZeneca R&D Japan
  • Principal Investigator: Kyoko Matsuguma, Kyushu Clinical Pharmacology Research Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5133C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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