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AZD5672 Absolute Bioavailability Study

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ClinicalTrials.gov Identifier: NCT00746837
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 2, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD5672 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers
Study Start Date : August 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during study periods ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

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): 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

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
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
AZD5672

Additional relevant MeSH terms:
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents