| July 18, 2008 |
| November 20, 2008 |
| June 2008 |
| August 2008 (final data collection date for primary outcome measure) |
| Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests. [ Time Frame: Test batteries will be performed at specified times both before and following study drug administration. ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00720421 on ClinicalTrials.gov Archive Site |
| Evaluation and characterization of the pharmacokinetics of AZD6280. [ Time Frame: Blood samples will be taken during the study. ] [ Designated as safety issue: No ] |
| Same as current |
| |
| A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator. |
| A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD7325 on Sedation, Cognition and Electroencephalogram (EEG) in Comparison With Lorazepam in Healthy Male Volunteers. |
The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity. |
| |
| Phase I |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study |
| Healthy Volunteer |
- Drug: AZD7325
- Drug: Lorazepam
|
- 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
- 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
- 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
- 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
|
| |
| |
| Completed |
| 16 |
| October 2008 |
| August 2008 (final data collection date for primary outcome measure) |
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
|
| Male |
| 18 Years to 55 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Netherlands |
| |
| NCT00720421 |
| Mark Smith, MD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals |
| D1140C00003, EudractCT 2008-001757-17 |
| AstraZeneca |
|
| Principal Investigator: |
J.M.A. Van Gerven, MD, PhD |
CHDR Leiden, the Netherlands |
|
|
| AstraZeneca |
| November 2008 |
