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AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

NCT ID: NCT00918398

Last Updated: 2009-07-30

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance

Detailed Description

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Conditions

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Healthy Postmenopausal Surgically Sterile Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD1981, 100 mg iv infusion

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

100 mg iv infusion, single dose, 4 hours infusion

2

AZD1981, 514 mg oral solution

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

514 mg oral solution, single dose

3

AZD1981, 500 mg oral tablet A

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose

4

AZD1981, 500 mg oral tablet B

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose

Interventions

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AZD1981

100 mg iv infusion, single dose, 4 hours infusion

Intervention Type DRUG

AZD1981

514 mg oral solution, single dose

Intervention Type DRUG

AZD1981

500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose

Intervention Type DRUG

AZD1981

500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Men or post-menopausal or surgically sterile women, aged 18 to 55 years
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria

* 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 result of the study, or the subject´s ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Lund, Sweden

Principal Investigators

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Eva Pettersson

Role: STUDY_DIRECTOR

AstraZeneca R&D, Lund, Sweden

Elisabeth Eden

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB, Uppsala, Sweden

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT No. 2009-010964-40

Identifier Type: -

Identifier Source: secondary_id

D9831C00003

Identifier Type: -

Identifier Source: org_study_id