NCT00750802

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

First QC Date

September 10, 2008

Last Update Submit

June 25, 2009

Conditions

Healthy Volunteer

Keywords

Phase I

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

EXPERIMENTAL
Drug: AZD6280

2

EXPERIMENTAL
Drug: AZD6280

3

ACTIVE COMPARATOR
Drug: Lorazepam

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD6280DRUG

10mg Capsule, oral, single-dose

1
LorazepamDRUG

2mg tablet, oral single-dose

Also known as: Ativan
3
PlaceboDRUG
4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Leiden, Netherlands

Location

MeSH Terms

Interventions

4-amino-8-(2,5-dimethoxyphenyl)-N-propylcinnoline-3-carboxamideLorazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

September 10, 2008

First Posted

September 11, 2008

Study Start

September 1, 2008

Study Completion

December 1, 2008

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

NL(1)