Overview

AZD9668 Relative Bioavailability

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
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).

- 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