A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Elderly Volunteers; Healthy Young Volunteers

Treatments: Drug: AZD3293; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739647

D5010C00001

Details and patient eligibility

About

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

Full 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

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

AZD3293

Experimental group

Description:

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

Treatment:

Drug: AZD3293

Placebo

Placebo Comparator group

Description:

Placebo given (2 subjects in each cohort)

Treatment:

Drug: Placebo