We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957437
First Posted: August 12, 2009
Last Update Posted: November 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Healthy Drug: AZD1305 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma [ Time Frame: From predose until 48 hours post last dose ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: August 2009
Study Completion Date: November 2009
Arms Assigned Interventions
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
Experimental: Part B1: single arm
AZD1305: ER test formulation 1
Drug: AZD1305
ER formulation 1, bid for 5 days
Experimental: Part B2: 3 way crossover
AZD1305: ER test formulation 2 (w/wo food) and reference formulation
Drug: AZD1305
Single Oral Dose, ER formulation 2

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957437


Locations
United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Helen Lunde AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Klaus Francke PAREXEL Early Phase Clinical Unit, London UK.
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00957437     History of Changes
Other Study ID Numbers: D3190C00016
First Submitted: August 10, 2009
First Posted: August 12, 2009
Last Update Posted: November 26, 2009
Last Verified: November 2009

Keywords provided by AstraZeneca:
Phase 1
healthy volunteer
male
pharmacokinetics
AZD1305