CClinicalTrials.gg
CompletedNCT01034982Updated Feb 5, 2010

AZD9668 Relative Bioavailability

A Phase 1 interventional study of AZD9668 and AZD9668 in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-05.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study is designed to investigate the pharmacokinetic behaviour of the free base formulation of AZD9668. The study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
03

In context

Lung Diseases, Obstructive

2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 28 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

Inclusion criteria

  • Provision of informed consent prior to any study-specific procedures
  • female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile).
  • Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg.
  • Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV-1/2 at the screening visit
  • Be a none smoker or ex-smoker who has stopped smoking for >6 months prior to visit 2 (pre-entry)

Exclusion criteria

Exclusion Criteria:

  • Any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs.
  • Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
  • History of cardiac arrhythmia
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    1

    tosylate salt tablet

    Drug: AZD9668

  • Experimental
    2

    free suspension

    Drug: AZD9668

  • Experimental
    3

    tosylate salt tablet

    Drug: AZD9668

  • Experimental
    4

    free suspension

    Drug: AZD9668

Interventions

  • DrugAZD9668

    20 mg

  • DrugAZD9668

    60 mg

06

What researchers measure

Primary outcomes

  1. Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of the free base of AZD9668 dosed as a suspension compared to the tosylate salt of AZD9668 dosed as a tablet formulation at two dose levels.

    Time frame: Frequent sampling occasions during the study

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse rate, 12-lead ECG, haematology, clinical chemistry and urinalysis)

    Time frame: Frequent sampling occasions during the study

07

Study locations

1 site
  • Research Site
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01034982
Lead sponsor
AstraZeneca
First posted
Dec 18, 2009
Start date
Nov 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 5, 2010

Study contacts

Emma Harrop
study director · AstraZeneca R&D
Rainard Fuhr
principal investigator · Parexel

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 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.

Start the discussion