NCT00681720

Brief Summary

The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1 anxiety

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1 anxiety

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

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

5 months

First QC Date

May 19, 2008

Last Update Submit

August 20, 2008

Conditions

Anxiety

Keywords

AnxietyGABA receptorsPositron Emission TomographyPETphase I

Outcome Measures

Primary Outcomes (1)

  • Positron emission tomography using the radioligand (11C)flumazenil

    4 times per subject

Secondary Outcomes (2)

  • To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.

    6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit

  • Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma

    3 times per subject. Up to 48 hours each time.

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD7325Drug: Radioligand (11C) flumazenil

Interventions

AZD7325DRUG

Single dose of oral solution or capsule. 3 times per subject.

1
Radioligand (11C) flumazenilDRUG

Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)

1

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
  • Clinically normal physical findings, medical history and laboratory values.

You may not qualify if:

  • Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
  • Intake of another investigational drug or participation in a clinical study the past 12 weeks.
  • Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

Related Publications (1)

  • Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.

    PMID: 28013354DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamideFlumazenil

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bo Fransson

    AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Eva Taavo

    AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

SE(1)