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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00957437
First received: August 10, 2009
Last updated: November 25, 2009
Last verified: November 2009

August 10, 2009
November 25, 2009
August 2009
Not Provided
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma [ Time Frame: From predose until 48 hours post last dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957437 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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 A: 3 way crossover
    AZD1305: ER test formulation 1 (w/wo food) and reference formulation
    Intervention: Drug: AZD1305
  • Experimental: Part B1: single arm
    AZD1305: ER test formulation 1
    Intervention: Drug: AZD1305
  • Experimental: Part B2: 3 way crossover
    AZD1305: ER test formulation 2 (w/wo food) and reference formulation
    Intervention: Drug: AZD1305
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
Not Provided

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00957437
D3190C00016
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Helen Lunde AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Klaus Francke PAREXEL Early Phase Clinical Unit, London UK.
AstraZeneca
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP