Healthy
Conditions
Keywords
AZD6765, Japanese and Caucasian Healthy Volunteers, Phase I study, Single and multiple Ascending Dose, Japanese volunteers
Brief summary
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
Interventions
DRUGAZD6765
single administration and once daily for 5 days
DRUGPlacebo
single administration and once daily for 5 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI): 18 to 27 kg/m 2 * Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening. * Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
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 prescription medication within 14 days of Day 1 * Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1 * Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments | During the study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine | During residential period |
| Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765. | During the study |
Countries
United States
Outcome results
None listed