Healthy Volunteer
Conditions
Keywords
AZD7325, Japanese Healthy Volunteers, Phase I study, Single Ascending Dose
Brief summary
This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.
Interventions
DRUGAZD7325
Capsule for oral, single dose
DRUGPlacebo
Placebo capsule for oral, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) : 18 to 27 kg/m 2
Exclusion criteria
* Clinically relevant disease and/or abnormalities (past or present) * Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator * Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day) * Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments. | During the study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters for AZD7325 | During residential period |
| Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects. | During the study |
Countries
United States
Outcome results
None listed