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Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

NCT ID: NCT00714337

Last Updated: 2010-12-10

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

Detailed Description

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Conditions

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Pharmacokinetics

Keywords

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Formulation pharmacokinetics

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

fasting state

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).

2

fasting state

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

One single oral dose of 90mg (3 x 30mg AZD1386 capsules)

3

non-fasting state

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

One single oral dose of 90mg (3 x 30mg AZD1386 capsules)

4

fasting state

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

5

non-fasting state

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

Interventions

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AZD1386

One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).

Intervention Type DRUG

AZD1386

One single oral dose of 90mg (3 x 30mg AZD1386 capsules)

Intervention Type DRUG

AZD1386

One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
* Healthy male volunteers with BMI between 18 and 30 kg/m2
* Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
* Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.

Exclusion Criteria

* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
* Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
* Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
* A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc \<360 ms
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 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 Pharmaceuticals

Principal Investigators

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Klaus Francke, MD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Clinical Pharmacology Research Unit

Other Identifiers

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EudraCT 2008-002150-37

Identifier Type: -

Identifier Source: secondary_id

D5090C00007

Identifier Type: -

Identifier Source: org_study_id