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Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

NCT ID: NCT00767052

Last Updated: 2009-06-30

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteer Safety Tolerability Pharmacokinetics AZD1236

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active

AZD1236 tablet

Group Type EXPERIMENTAL

AZD1236

Intervention Type DRUG

75mg once daily or 75mg twice daily will be administered in multiple dose part.

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet matching to the active in multiple dose part.

Relative bioavailability

AZD1236 Oral suspension

Group Type OTHER

AZD1236

Intervention Type DRUG

75mg single dose will be administered in relative bioavailability part.

Relative bioavailability tablet

AZD1236 tablet

Group Type OTHER

AZD1236

Intervention Type DRUG

75mg oral suspension single dose will be administered in relative bioavailability part.

Interventions

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AZD1236

75mg once daily or 75mg twice daily will be administered in multiple dose part.

Intervention Type DRUG

Placebo

Placebo tablet matching to the active in multiple dose part.

Intervention Type DRUG

AZD1236

75mg single dose will be administered in relative bioavailability part.

Intervention Type DRUG

AZD1236

75mg oral suspension single dose will be administered in relative bioavailability part.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed informed consent prior to any study specific procedures
* Body Mass Index (BMI) between 19-27 kg/m2

Exclusion Criteria

* Receipt of another investigational drug in the 4 months before dosing in this study
* Acute illness which requires medical intervention within 2 weeks of Visit 2.
* Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure \> 140 mmHg systolic or \>90 mmHg diastolic, pulse\<= 50 or =\> 90 beats per minute
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Shunji Matsuki, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kyushu Clinical Pharmacology Research Clinic

Locations

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Research Site

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D4260C00006

Identifier Type: -

Identifier Source: org_study_id