AZD6088 Single Ascending Dose Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AZD6088

Study type: Interventional

Funder types: Industry

Identifiers

NCT00931541

D0840C00007

EudraCT N0. 2008-007936-17

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

A

Experimental group

Description:

AZD6088 oral solution

Treatment:

Drug: AZD6088

B

Experimental group

Description:

Placebo oral solution

Treatment:

Drug: Placebo