A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.

NCT00424697 | Completed Phase 1

• 1 other identifier: CRH104150
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Data suggests that imaging activity of the brain can measure the effects of anti-anxiety drugs. This study will investigate the effect of GW876008 on areas of the brain involved with thinking and emotion

Conditions

Healthy Subjects

Keywords

Brain imaging,; fMRI,; stimulation,; pharmacodynamics,; tolerability,; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Differences in brain activation elicited by Matching Emotional Face Expression paradigm following single oral doses of GW876008 and lorazepam on day 1, sessions 1-4

Secondary Outcomes (16)

• GW876008 blood levels

  pre-dose & post-dose, sessions 1-4

• clinical rating scales change after dosing: questionnaires collected

  pre-dose & up to 6-8 hours post-dose.

• Safety: 12-lead ECG, vital signs, adverse events, clinical labs

• fMRI BOLD neuroanatomical structure of the emotional brain neurocircuitry and connectivity

• fMRI BOLD Signal characteristics and connectivity

Interventions

placebo DRUG

lorazepam DRUG

GW876008 DRUG

Also known as: placebo, lorazepam

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females aged 18-50 years, inclusive.
• STAI-trait score = or \> 40.
• STAI-state score \<50th percentile of the normal population distribution.
• Female subjects of non-childbearing.
• Female subjects of childbearing potential must agree to use appropriate contraception.
• Healthy subjects, as determined by a responsible physician
• Body weight ≥ 50 kg (110 lbs), and BMI within the range 19-29.9 kg/m2 inclusive.
• Demonstrates no significant evidence of active disease, physical or mental impairment when assessed by qualified personnel
• Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
• Normal electrocardiogram.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Read, comprehend, and write English at a sufficient level to complete study-related materials.
• Provide a signed and dated written informed consent prior to study participation

You may not qualify if:

• As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
• Any history of suicidal attempts or behaviour.
• Any history or current diagnosis of a psychiatric illness.
• Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
• Abnormal pepsinogen I level at screening.
• Liver Function Tests (LFTs) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT
• Any other clinically significant laboratory abnormality.
• Positive faecal occult blood test.
• Positive pre-study urine drug/alcohol breath screen.
• Positive pre-study HIV 1/2, Hepatitis B surface antigen and positive Hepatitis C antibody result within 3 months of the start of the study.
• Pre-existing or current Helicobactor pylori infection.
• History of alcohol/drug abuse or dependence within 12 months of the study
• Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
• History of peptic ulcer disease.
• Abnormal screening ECG

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Lorazepam; GW 876008

Intervention Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials, MBChB, MFPM

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

US (1)