A Study Conducted Over 3 Periods to Look at the Drug in the Body

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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A study conducted over 3 periods to look at the drug in the body.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single Oral dose AZD8329 tablet (fasting)

Group Type EXPERIMENTAL

AZD8329

Intervention Type DRUG

tablet

2

Single Oral dose AZD8329 solution (fasting)

Group Type EXPERIMENTAL

AZD8329

Intervention Type DRUG

Solution

3

Single Oral dose AZD8329 tablet (Fed)

Group Type EXPERIMENTAL

AZD8329

Intervention Type DRUG

tablet

Interventions

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AZD8329

tablet

Intervention Type DRUG

AZD8329

Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
* suitable veins for cannulation or repeated venepuncture
* Subjects should have a body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria

* Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
* Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome
* Suspicion of known Gilbert's disease
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes