Healthy, Safety
Conditions
Keywords
Safety, Tolerability, Phase I
Brief summary
This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624
Interventions
DRUGAZD2624
oral suspension, 3 doses
DRUGPlacebo
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
* Healthy young male Japanese volunteers
Exclusion criteria
* Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1 * Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1 * Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1 * Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs | All assessments are made at each visit, at least daily, during the study. |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma | Blood samples will be taken before and after study drug administration. |
| Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624 | A single blood sample will be obtained |
Countries
Japan
Outcome results
None listed