AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00918398
First received: June 10, 2009
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance


Condition Intervention Phase
Healthy
Postmenopausal
Surgically Sterile Women
Drug: AZD1981
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: An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK samples for AZD1981 from both blood and urine [ Time Frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events and laboratory safety lab) [ Time Frame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: June 2009
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1
AZD1981, 100 mg iv infusion
Drug: AZD1981
100 mg iv infusion, single dose, 4 hours infusion
Experimental: 2
AZD1981, 514 mg oral solution
Drug: AZD1981
514 mg oral solution, single dose
Experimental: 3
AZD1981, 500 mg oral tablet A
Drug: AZD1981
500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
Experimental: 4
AZD1981, 500 mg oral tablet B
Drug: AZD1981
500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Men or post-menopausal or surgically sterile women, aged 18 to 55 years
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918398

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Elisabeth Eden Quintiles AB, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
ClinicalTrials.gov Identifier: NCT00918398     History of Changes
Other Study ID Numbers: D9831C00003, EudraCT No. 2009-010964-40
Study First Received: June 10, 2009
Last Updated: July 29, 2009
Health Authority: Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on August 28, 2014