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AZD5672 Absolute Bioavailability Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00746837
First received: September 3, 2008
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)


Condition Intervention Phase
Healthy Volunteers
 Drug: AZD5672
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses
 Drug: AZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
Experimental: 2
2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose
 Drug: AZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
Drug: AZD5672
50 mg od, 12 days
Drug: AZD5672
150mg od, 12 days

  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.
  • Females should not be of childbearing potential
  • Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

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 may influence the results of the study, or the subject's ability to participate
  • Unsuitable venous access for intravenous studies
  • Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746837

Locations
United Kingdom
Research Site
Harrow, London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD, PhD AstraZeneca R&D, Charnwood, UK
Principal Investigator: Tania Hugo PAREXEL Clinical Pharmacology Research Unit
  More Information

No publications provided

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park
ClinicalTrials.gov Identifier: NCT00746837     History of Changes
Other Study ID Numbers: D1710C00018, EudraCt nr 2008-003933-25
Study First Received: September 3, 2008
Last Updated: November 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD5672

ClinicalTrials.gov processed this record on June 17, 2013