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AZD5672 Absolute Bioavailability Study

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AZD5672

Study type

Interventional

Funder types

Industry

Identifiers

NCT00746837
EudraCt nr 2008-003933-25
D1710C00018

Details and patient eligibility

About

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)

Enrollment

26 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

26 participants in 2 patient groups

1
Experimental group
Description:
Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses
Treatment:
Drug: AZD5672
Drug: AZD5672
Drug: AZD5672
2
Experimental group
Description:
2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose
Treatment:
Drug: AZD5672
Drug: AZD5672
Drug: AZD5672

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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