AZD9668 Relative Bioavailability

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01035411

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical study will aid future formulation development and optimisation of AZD9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: AZD9668 Drug: AZD9668 Drug: AZD9668	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

An Open-label, Single-centre, 3-way Single Dose Crossover Study to Assess the Relative Bioavailability After Oral Administration of a Tablet Variant of AZD9668 Compared to AZD9668 Tablets and to Further Investigate the Safety and Tolerability of AZD9668 in Healthy Subjects

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD9668 2X30mg tablet	Drug: AZD9668 2 x 30 mg batch DLE494 Drug: AZD9668 2 x 30 mg batch DLF497 Drug: AZD9668 2 x 30 mg tablet variant 1

Arm

Intervention/Treatment

Experimental: 1

AZD9668 2X30mg tablet

Drug: AZD9668

2 x 30 mg batch DLE494

Drug: AZD9668

2 x 30 mg batch DLF497

Drug: AZD9668

2 x 30 mg tablet variant 1

Outcome Measures

Primary Outcome Measures

Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of a tablet variant of AZD9668 compared to AZD9668 tablets. [Frequent sampling occasions during the study]

Secondary Outcome Measures

Safety variables (adverse events, vital signs, haematology, clinical chemistry, urinalysis and 12-lead ECG) [Frequent sampling occasions during the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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) or of child bearing potential
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:

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
Any ECG abnormality (including cardiac arrhythmia) which in the opinion of the investigator may put the subject at risk

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Berlin		Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Emma Harrop, AstraZeneca R&D
Principal Investigator: Rainard Fuhr, Parexel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01035411

Other Study ID Numbers:

D0520C00007

First Posted:

Dec 18, 2009

Last Update Posted:

Jan 29, 2013

Last Verified:

Feb 1, 2010

Keywords provided by AstraZeneca

COPD

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 29, 2013