A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: Lorazepam; Drug: AZD6280

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750802

D0850C00014

Eudract # 2008-001757-17

Details and patient eligibility

About

The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.
• Female subjects must be of non-child bearing potential.

Exclusion criteria

• Clinically significant illness within 2 weeks before the study start.
• Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
• Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
• Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD6280

Drug: AZD6280

2

Experimental group

Treatment:

Drug: AZD6280

Drug: AZD6280

3

Active Comparator group

Treatment:

Drug: Lorazepam

4

Placebo Comparator group

Treatment:

Drug: Placebo