Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
- Registration Number
- NCT00796965
- Lead Sponsor
- AstraZeneca
- Brief Summary
Single Ascending Dose Study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Provision of Informed Consent
- Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture
Exclusion Criteria
- Inability to understand or cooperate with given information
- Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
- Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD7268 - 2 Placebo -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential. Safety assessments are made at each visit, at least daily, during the study.
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics of AZD7268 in plasma and urine. Blood and urine samples will be taken during the study. To assess the effect of food on the safety and pharmacokinetic profile of AZD7268. Safety assessments and blood and urine samples will be taken throughout the study.
Trial Locations
- Locations (1)
Research Site
🇺🇸Philadelphia, Pennsylvania, United States