Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject

NCT ID: NCT01161355

Last Updated: 2011-02-09

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-06-30

Brief Summary

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The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of \[14C\]AZD9668 in healthy male subjects.

Detailed Description

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This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of \[14C\]AZD9668 in healthy male subjects.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD9668

Tablets and intravenous (IV) dose

Group Type EXPERIMENTAL

AZD9668

Intervention Type DRUG

Tablets of AZD9668 and IV dose of \[C14\]AZD9668

Interventions

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AZD9668

Tablets of AZD9668 and IV dose of \[C14\]AZD9668

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

Exclusion Criteria

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Principal Investigators

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Joanna Marks-Konczalik

Role: STUDY_DIRECTOR

AstraZeneca

Sharan Sidhu, MB ChB, BAO,

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

Ruddington, Nottingham, United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D0520C00021

Identifier Type: -

Identifier Source: org_study_id

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