Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

AstraZeneca72 enrolled

Overview

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD2516DRUG

Solution administered once orally

PlaceboDRUG

Solution administered only once

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old. * Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 Exclusion Criteria: * History of previous or ongoing psychiatric disease. * Abnormalities in ECG that may interfere with interpretation of data.

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

Time frame: From first to last visit

Secondary Outcomes

Safety and tolerability of AZD2516 by assessment of non-serious adverse events

Time frame: Collected from start of residential period until last visit.

Determine the single ascending dose pharmacokinetics of AZD2516

Time frame: PK sampling taken at defined timepoints during residential period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.