ClinicalTrials.gg
Sign In
CompletedNCT00746837Updated Dec 2, 2010

AZD5672 Absolute Bioavailability Study

A Phase 1 interventional study of AZD5672 and AZD5672 in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-02.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Healthy Volunteers

Keywords

  • AZD5672
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    1

    Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses

    Drug: AZD5672

  • 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

Interventions

  • DrugAZD5672

    single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period

  • DrugAZD5672

    50 mg od, 12 days

  • DrugAZD5672

    150mg od, 12 days

06

What researchers measure

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during study periods

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment periods

07

Study locations

1 site
  • Research Site
    Harrow, London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00746837
Lead sponsor
AstraZeneca
First posted
Sep 4, 2008
Start date
Aug 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Dec 2, 2010

Study contacts

Mark Layton, MD, PhD
study director · AstraZeneca R&D, Charnwood, UK
Tania Hugo
principal investigator · PAREXEL Clinical Pharmacology Research Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Azd-5672

Other studies from this sponsor

AstraZeneca →

Start the discussion