Healthy Volunteer
Conditions
Keywords
Phase I, Pharmacokinetics
Brief summary
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.
Interventions
DRUGAZD6280
oral
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects must be of non-child bearing potential.
Exclusion criteria
* Clinically significant illness within 2 weeks before the study start. * Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit * Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2 * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs | Assessments are made at each visit, at least daily, during the study. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation and characterization of the pharmacokinetics of AZD6280 | Blood samples will be taken during the study. |
| Evaluation of the pharmacodynamic effects of AZD6280 | Test batteries will be performed at specified times both before and following study drug administration |
| Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280. | A single blood sample will be obtained. |
Countries
United States
Outcome results
None listed