AZD6088 Single Ascending Dose Study

AstraZeneca35 enrolled

Overview

The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

AZD6088DRUG

Oral solution. Each subject will receive a single-dose of AZD6088.

PlaceboDRUG

Oral solution. Each subject will receive a single-dose of placebo.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture. * Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator. * Normal and suitable EEG, as judged by a neurologist Exclusion Criteria: * History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder. * Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. * Any clinically important abnormalities in the ECG.

Locations (1)

Research Site

London Bridge, Greater London, United Kingdom

Outcomes

Primary Outcomes

Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)

Time frame: Sampling occasions during all visits.

Secondary Outcomes

Pharmacokinetics

Time frame: Intense PK-sampling during 3 pre-defined study days for PK profiling.

Pharmacodynamics

Time frame: Sampling occasions during 3 pre-defined study days.

Data from ClinicalTrials.gov

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