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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
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00957437     History of Changes
Other Study ID Numbers: D3190C00016
Study First Received: August 10, 2009
Last Updated: November 25, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 23, 2013