NCT00902772

Brief Summary

The purpose of this study is to examine the abuse potential of AZD7325.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2009

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

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

First QC Date

May 12, 2009

Last Update Submit

September 22, 2009

Conditions

Recreational CNS Depressant Use

Keywords

Recreational CNS depressantAbuse liabilityAbuse potentialHealthy Recreational CNS Depressant Users

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scales

    Daily during Visit 2 through 9

Secondary Outcomes (1)

  • Columbia Suicide-Severity Rating Scale

    Prior to each treatment period

Study Arms (7)

A

PLACEBO COMPARATOR

Placebo

Drug: Placebo

B

ACTIVE COMPARATOR

Lorazepam

Drug: Lorazepam

C

ACTIVE COMPARATOR

Lorazepam

Drug: Lorazepam

D

ACTIVE COMPARATOR

Lorazepam

Drug: Lorazepam

E

EXPERIMENTAL

AZD7325

Drug: AZD7325

F

EXPERIMENTAL

AZD7325

Drug: AZD7325

G

EXPERIMENTAL

AZD7325

Drug: AZD7325

Interventions

LorazepamDRUG

mg, oral dose

BCD
AZD7325DRUG

mg, oral dose

EFG
PlaceboDRUG
A

Eligibility Criteria

Age18 Months - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Recreational CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening
  • Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
  • Willing and able to abide by all study requirements and restrictions

You may not qualify if:

  • Unwillingness of inability to abstain from recreational drug use for the duration of the study from screening until follow-up
  • Positive breath alcohol test prior to dosing
  • Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or safety laboratories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

Lorazepam4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Myroslava K Romach, MD

    Kendle Early Stage - Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 15, 2009

Study Start

May 1, 2009

Study Completion

September 1, 2009

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

CA(1)