A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers

AstraZeneca1 site in 1 country35 target enrollmentJune 2009

ConditionsHealthy Volunteers

InterventionsAZD6088 Placebo

DrugsAZD6088 Placebo

Overview

Phase: Phase 1
Intervention: AZD6088
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 35
Locations: 1
Primary Endpoint: Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

August 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

A

AZD6088 oral solution

Intervention: AZD6088

B

Placebo oral solution

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Sampling occasions during all visits.

Secondary Outcomes

Pharmacokinetics(Intense PK-sampling during 3 pre-defined study days for PK profiling.)
Pharmacodynamics(Sampling occasions during 3 pre-defined study days.)