Healthy
Conditions
Keywords
Phase I, Japanese Healthy volunteer
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.
Interventions
DRUGAZD7268
Capsule, Oral, BID
DRUGPlacebo
Capsule, Oral, BID
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate the safety and tolerability of AZD7268 by Adverse Events. | From first dosing throughout the treatment period and including the follow-up period |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Japan
Outcome results
None listed