A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AZD3293
- Conditions
- Healthy Young Volunteers
- Sponsor
- AstraZeneca
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Adverse event monitoring.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
Detailed Description
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female (of non-childbearing potential) subjects
- •Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion Criteria
- •History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
- •History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
- •History of 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
Arms & Interventions
AZD3293
Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg
Intervention: AZD3293
Placebo
Placebo given (2 subjects in each cohort)
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse event monitoring.
Time Frame: From baseline up to 10 days.
Assessment of vital signs and physical examination.
Time Frame: From baseline up to 10 days.
The vital signs of body temperature, blood pressure and pulse are going to be measured.
Clinical laboratory tests: hematology.
Time Frame: From baseline up to 10 days.
Clinical laboratory tests: urine analysis.
Time Frame: From baseline up to 10 days.
Evaluation of 12-lead digital electrocardiogram (ECG).
Time Frame: From baseline up to 10 days.
QT/QTc interval, rhythm, rate, morphology is going to be measured.
Assessment of telemetry.
Time Frame: From baseline up to 10 days.
As reported by investigator.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: From baseline up to 10 days.
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Secondary Outcomes
- Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).(Up 4 days)
- Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.(Up to 4 days.)
- Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.(Up to 4 days.)
- Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.(Up to 4 days.)
- Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).(Up to 4 days.)
- Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).(Up to 4 days.)