Clinical trial NCT02005211: A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Keywords: AZD3293
Healthy volunteers
Young volunteers
Elderly volunteers
Japanese volunteers
Phase 1
Single and multiple ascending dose study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: Day of first dose to follow up
Secondary outcomes:
measure: PK Cmax - Overall Study
timeFrame: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
measure: PK AUC - Overall Study (SAD & MAD Parts)
timeFrame: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
measure: Biomarker
timeFrame: Pre dose vs Day 14
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Robert C Alexander, MD
role: STUDY_DIRECTOR
affiliation: Sugioka Memorial Hospital, Medical Co. LTA
name: Kei Sakamoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: