AZD9668 Relative Bioavailability

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01034982
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 4
• Duration (Days): 30
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief 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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: A Phase I Open-label, Single-centre, Two Cohort Crossover Study to Assess the Relative Bioavailability After Oral Administration of AZD9668 Free Base Dosed as a Suspension Compared to AZD9669 Tosylate Salt Dosed as a Tablet
• 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 tosylate salt tablet	Drug: AZD9668; 20 mg
Experimental: 2 free suspension	Drug: AZD9668; 20 mg
Experimental: 3 tosylate salt tablet	Drug: AZD9668; 60 mg
Experimental: 4 free suspension	Drug: AZD9668; 60 mg

Outcome Measures

Primary Outcome Measures

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. [Frequent sampling occasions during the study]

Secondary Outcome Measures

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

• 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

• History of cardiac arrhythmia

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.

• ClinicalTrials.gov Identifier: NCT01034982
• Other Study ID Numbers: D0520C00017
• First Posted: Dec 18, 2009
• Last Update Posted: Feb 5, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: COPD
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Feb 5, 2010