AzTrials
AzTrials

Healthy SubjectsPhase 1NCT00424697

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

A Phase 1 study testing lorazepam and GW876008 in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
lorazepam and GW876008
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
Mar 2007to Dec 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
  • Systolic blood pressure < 90mmHg or >140mmHg; diastolic blood pressure < 60mmHg or > 90mmHg; pulse rate < 40bpm or > 90bpm.
  • Participation in a clinical trial with a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
  • History or current diagnosis of acute narrow angle glaucoma.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
  • Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
  • Subjects who are left handed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GW876008 and Lorazepam (Comparator) in Healthy Subjects.

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

Being tested
placebo, lorazepam, GW876008
Keywords
Brain imaging,, fMRI,, stimulation,, pharmacodynamics,, tolerability,, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

  • lorazepamDrug

  • GW876008Drug

    Also called placebo, lorazepam

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. GW876008 blood levels

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

  2. clinical rating scales change after dosing: questionnaires collected

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

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

  4. fMRI BOLD neuroanatomical structure of the emotional brain neurocircuitry and connectivity

  5. fMRI BOLD Signal characteristics and connectivity

  6. fMRI BOLD Response in the emotional brain neurocircuitry and occipital cortex.

  7. ETCo2 in mm Hg, to be recorded for the duration of the scan session and be synchronized with the single fMRI procedure timing

  8. Visual Analog Scale (VAS) measurements of sleepiness, alertness, calm, tension, and anxiety performed before dosing (baseline), pre-fMRI session, post-fMRI session and just before leaving the facility.

  9. Association between the anxiety trait (STAI-trait, test battery for neuroticism or liability for Anxiety Disorders) collected at screening and the various pharmacodynamic parameters measured in the various testing conditions.

  10. GW876008 concentration to determine pharmacokinetic parameters to be collected twice per session,

  11. Pharmacogenetic (PGx) assessments

  12. Safety and tolerability of GW876008 to include Vital signs semi-supine; respiratory rate, pulse oximetry and ECG.

  13. Clinical laboratory tests

  14. fMRI BOLD ALS signal.

  15. Heart rate (HR; beats per minute), to be recorded for the whole duration of the scan session and to be synchronized with the single fMRI procedure timing.

  16. Respiratory rate (RR: inspiration per minute), to be recorded for the duration of scan session and be synchronized with the single fMRI procedure timing. .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424697
Sponsor's protocol ID
CRH104150
Status last verified
Oct 2010
First submitted
17 Jan 2007
Last updated
15 Oct 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lorazepam and GW876008 in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in