AZD9668 Relative Bioavailability

NCT ID: NCT01035411

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

1

AZD9668 2X30mg tablet

Group Type: EXPERIMENTAL

AZD9668

Intervention Type: DRUG

2 x 30 mg batch DLE494

AZD9668

Intervention Type: DRUG

2 x 30 mg batch DLF497

AZD9668

Intervention Type: DRUG

2 x 30 mg tablet variant 1

Interventions

AZD9668

2 x 30 mg batch DLE494

Intervention Type: DRUG

AZD9668

2 x 30 mg batch DLF497

Intervention Type: DRUG

AZD9668

2 x 30 mg tablet variant 1

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Harrop

Role: STUDY_DIRECTOR

AstraZeneca R&D

Rainard Fuhr

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D0520C00007

Identifier Type: -

Identifier Source: org_study_id