A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: AZD7325; Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00720421

D1140C00003

EudractCT 2008-001757-17

Details and patient eligibility

About

The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male aged 18 to 55 years on screening

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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16 participants in 4 patient groups

1

Other group

Description:

AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy

Treatment:

Drug: AZD7325

Drug: Lorazepam

Drug: Lorazepam

Drug: AZD7325

Drug: AZD7325

2

Other group

Description:

AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 1mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy

Treatment:

Drug: AZD7325

Drug: Lorazepam

Drug: Lorazepam

Drug: AZD7325

Drug: AZD7325

3

Other group

Description:

AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy

Treatment:

Drug: AZD7325

Drug: Lorazepam

Drug: Lorazepam

Drug: AZD7325

Drug: AZD7325

4

Other group

Description:

AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy

Treatment:

Drug: AZD7325

Drug: Lorazepam

Drug: Lorazepam

Drug: AZD7325

Drug: AZD7325