Healthy
Conditions
Keywords
Phase 1, Healthy Volunteer
Brief summary
Multiple Ascending Dose Study
Interventions
DRUGPlacebo
Capsule, Oral BID
DRUGAZD7268
Capsule, Oral, QD
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of Informed Consent * Healthy male subjects and female subjects (of non-child bearing potential) * 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, or Hepatitis C test * History of seizure (including infancy febrile seizures) or family history of seizure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential. | Safety assessments are made at each visit, at least daily, during the study. |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetics of AZD7268 in plasma. | Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8 |
Countries
United States
Outcome results
None listed