Title
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly
Phase
Phase 1Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Healthy Japanese Young and Elderly Male and Non-fertile Female VolunteersIntervention/Treatment
azd3293 ...Study Participants
114This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.
This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.
Oral solution
Oral solution
AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1.
Inclusion Criteria: Healthy Japanese elderly and young males and females (of non-childbearing potential) Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg Exclusion Criteria: Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs. Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products. Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
| Event Type | Organ System | Event Term | Placebo Part 1 | AZD3293 15 mg Part 1 | AZD3293 50 mg Part 1 | AZD3293 150 mg Part 1 | AZD3293 15 mg Part 2 | AZD3293 50 mg Part 2 | Placebo Part 2 |
|---|
Safety - Number of subjects reporting any adverse events during the study
Biomarker (Abeta 1-40; A beta 1-42) % change from baseline
Pharmacokinetic maximum concentration
Pharmacokintic Area Under the Curve (0 to t)
