Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers
- Registration Number
- NCT01116011
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Provision of Informed Consent
- Healthy male subjects, with suitable veins for cannulation or repeated venipuncture
Exclusion Criteria
- Inability to understand or cooperate with given information
- Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
- History of seizure (including infant febrile seizures) or family history of seizure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD7268 AZD7268 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Investigate the safety and tolerability of AZD7268 by Adverse Events. From first dosing throughout the treatment period and including the follow-up period
- Secondary Outcome Measures
Name Time Method Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma Blood samples will be taken from pre-dose until 48 hours post last dose Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine Urine samples will be taken from post first dose until 48 hours post last dose.
Trial Locations
- Locations (1)
Research Site
🇯🇵Kanagawa, Sagamihara, Japan