Clinical trial NCT01739647: A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Young Volunteers
Healthy Elderly Volunteers
Keywords: AZD3293
Healthy volunteers
Elderly volunteers
Phase 1
Single Ascending Dose Study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
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 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

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

Primary outcomes:
measure: Adverse event monitoring.
timeFrame: From baseline up to 10 days.
measure: Assessment of vital signs and physical examination.
timeFrame: From baseline up to 10 days.
measure: Clinical laboratory tests: hematology.
timeFrame: From baseline up to 10 days.
measure: Clinical laboratory tests: urine analysis.
timeFrame: From baseline up to 10 days.
measure: Evaluation of 12-lead digital electrocardiogram (ECG).
timeFrame: From baseline up to 10 days.
measure: Assessment of telemetry.
timeFrame: From baseline up to 10 days.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: From baseline up to 10 days.
Secondary outcomes:
measure: Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).
timeFrame: Up 4 days
measure: Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.
timeFrame: Up to 4 days.
measure: Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.
timeFrame: Up to 4 days.
measure: Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.
timeFrame: Up to 4 days.
measure: Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).
timeFrame: Up to 4 days.
measure: Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).
timeFrame: Up to 4 days.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: AstraZeneca
name: Robert C Alexander, MD
role: STUDY_DIRECTOR
affiliation: Parexel
name: Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
References: