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

NCT00720421 | Completed Phase 1

• 2 other identifiers: D1140C00003EudractCT 2008-001757-17
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Phase I; pharmacodynamic study

Outcome Measures

Primary Outcomes (1)

• Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests.

  Test batteries will be performed at specified times both before and following study drug administration.

Secondary Outcomes (1)

• Evaluation and characterization of the pharmacokinetics of AZD6280.

  Blood samples will be taken during the study.

Study Arms (4)

1

OTHER

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

Drug: AZD7325; Drug: Lorazepam

2

OTHER

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

Drug: AZD7325; Drug: Lorazepam

3

OTHER

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

Drug: AZD7325; Drug: Lorazepam

4

OTHER

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

Drug: AZD7325; Drug: Lorazepam

Interventions

AZD7325 DRUG

AZD7325 10 mg oral 2 capsules

1; 2; 3; 4

Lorazepam DRUG

Lorazepam 1 mg oral 2 tablets

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male aged 18 to 55 years on screening

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, Netherlands

Location

MeSH Terms

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide; Lorazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• J.M.A. Van Gerven, MD, PhD

  CHDR Leiden, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2008-11

Locations

NL (1)