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

November 25, 2009 updated by: AstraZeneca

A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: 3 way crossover
AZD1305: ER test formulation 1 (w/wo food) and reference formulation
Drug: AZD1305
Single Oral Dose, ER formulation 1
Drug: AZD1305
ER formulation 1, bid for 5 days
Drug: AZD1305
Single Oral Dose, ER formulation 2
Experimental: Part B1: single arm
AZD1305: ER test formulation 1
Drug: AZD1305
Single Oral Dose, ER formulation 1
Drug: AZD1305
ER formulation 1, bid for 5 days
Drug: AZD1305
Single Oral Dose, ER formulation 2
Experimental: Part B2: 3 way crossover
AZD1305: ER test formulation 2 (w/wo food) and reference formulation
Drug: AZD1305
Single Oral Dose, ER formulation 1
Drug: AZD1305
ER formulation 1, bid for 5 days
Drug: AZD1305
Single Oral Dose, ER formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
Time Frame: From predose until 48 hours post last dose
From predose until 48 hours post last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight
Time Frame: Frequent safety measurements during the study, from screening period to follow-up
Frequent safety measurements during the study, from screening period to follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Helen Lunde, AstraZeneca R&D, Mölndal, Sweden
  • Principal Investigator: Klaus Francke, PAREXEL Early Phase Clinical Unit, London UK.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 26, 2009

Last Update Submitted That Met QC Criteria

November 25, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D3190C00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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