AZD9668 Relative Bioavailability

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: AZD9668

• Registration Number: NCT01034982
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD9668	tosylate salt tablet
2	AZD9668	free suspension
3	AZD9668	tosylate salt tablet
4	AZD9668	free suspension

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety variables (adverse events, blood pressure, pulse rate, 12-lead ECG, haematology, clinical chemistry and urinalysis)	Frequent sampling occasions during the study

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany