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Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305

NCT ID: NCT00957437

Last Updated: 2009-11-26

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 healthy volunteer male pharmacokinetics AZD1305

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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Part A: 3 way crossover

AZD1305: ER test formulation 1 (w/wo food) and reference formulation

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Single Oral Dose, ER formulation 1

Part B1: single arm

AZD1305: ER test formulation 1

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

ER formulation 1, bid for 5 days

Part B2: 3 way crossover

AZD1305: ER test formulation 2 (w/wo food) and reference formulation

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Single Oral Dose, ER formulation 2

Interventions

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AZD1305

Single Oral Dose, ER formulation 1

Intervention Type DRUG

AZD1305

ER formulation 1, bid for 5 days

Intervention Type DRUG

AZD1305

Single Oral Dose, ER formulation 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Minimum Eligible Age

18 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

Principal Investigators

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Helen Lunde

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Klaus Francke

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Unit, London UK.

Locations

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Research Site

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D3190C00016

Identifier Type: -

Identifier Source: org_study_id