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

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ClinicalTrials.gov Identifier: NCT00957437
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Study Start Date : August 2009
Actual Study Completion Date : November 2009

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
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



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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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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.

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.

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

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