AZD6088 Single Ascending Dose Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00931541

Enrollment

Registered

2009-07-02

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2009-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Safety, Tolerability, Healthy

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.

Interventions

DRUGAZD6088

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)	Sampling occasions during all visits.

Secondary

Measure	Time frame
Pharmacokinetics	Intense PK-sampling during 3 pre-defined study days for PK profiling.
Pharmacodynamics	Sampling occasions during 3 pre-defined study days.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026