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Depressive Disorder, MajorPhase 1NCT00559299

Patient Tolerability Study of GSK163090

A Phase 1 study testing GSK163090 in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), 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
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Trial summary

The purpose of this study is to determine the safety and tolerability of a new drug, GSK163090, which is being developed for the treatment of depression and anxiety disorders. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
GSK163090
How many people
20 participants
Where
1 siteUnited States
Study dates
Nov 2007to Jun 2008
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects between the ages of 18 - 65 years with a psychiatric diagnosis of a MDE associated with MDD according to DSM-IV-TR (296.2/296.3) whose symptoms are considered mild to moderate and have not been taking antidepressant medication at the time of screening and for at least 4 weeks prior to randomisation.
  • If female, the subject is eligible to enter and participate in this study if she is not lactating and is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [defined as one year without menses for women >45 years of age]); is surgically sterile [via hysterectomy and/or removal of the ovaries] or,
  • Child-bearing potential, has a negative pregnancy test at both screen and baseline (prior to investigational product administration), and agrees to acceptable methods of contraception
  • Body weight ≥ 50 kg and body mass index (BMI) between 18.5 - 35.0 kg/m2 inclusive.
  • Capable of giving informed consent and can comply with the study requirements and timetable.
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  • Subjects have a HAM-D17 score > 18 and <25 at screening and baseline.
  • The subject must be able to read, comprehend and record information.
  • Non-smoker or light (< 10 cigarettes per day) smoker.
  • Agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Who cannot join

  • Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
  • As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study.
  • The subject has a history of a drug reaction or other allergy which in the opinion of the physician responsible contraindicates their participation in the study.
  • The subject is currently participating or has participated in a clinical trial with a new chemical entity or any investigational drug during the previous 2 months. In addition, the subject has not participated in clinical trials with more than 3 new chemical entities in the past 12 months.
  • The subject has a screening ECG with parameters outside ranges defined in the protocol
  • The subject has a pulse rate <45 or >100 bpm and/or a systolic blood pressure >150 and/or <90 and/or a diastolic blood pressure >90 and <50.
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  • History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
  • The subject has any liver function test (LFT) elevated >1.5 times above the reference range at pre-study screening that remain elevated with a repeat LFT.
  • Any other clinically significant laboratory abnormality.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) 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, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Use of monoamine oxidase inhibitors (MAOI) and linezolid (antibiotic) for 1 month prior to first dose of study medication.
  • Abuse of alcohol defined as an average weekly intake of greater than 21 units for males and 14 units for females or an average daily intake of greater than 3 units for males and 2 units for females. 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
  • Consumption of grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the last PK sample.
  • The subject is unable to abstain from strenuous physical activity for 48 h prior to screening and follow up and for 48 h prior to and 48 h after each treatment period.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 90 day period
  • An unwillingness of male subjects to abstain from, or use a condom during, sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until 90 days following administration of the last dose of study medication
  • OR
  • An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.
  • 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.
  • Subjects who, in the investigator's judgement, pose a homicidal or serious suicidal risk, have made a suicide attempt within 6 months preceding screening or who have ever been homicidal.
  • The subject has a history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
  • The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
  • The subject has tested positive for HIV.
  • The subject has a past history of drug abuse or dependence according to DSM-IV TR criteria within the past 12 months or has tested positive for urine drugs of abuse at pre-study screening.
  • The subject has any history of serotonin syndrome or in the investigator's judgement, a history of clinical significant intolerance to SSRIs.
  • Subjects with a history of migraine headaches that respond to treatment with triptan medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Wichita, Kansas, 67211

Other trials in United States

About this study

Official title: A Randomized, Single-blind, Placebo-controlled, 2 Part Study to Evaluate the Safety and Tolerability of GSK163090 at Single and Repeat Doses in Subjects With MDD

The purpose of this study is to determine the safety and tolerability of a new drug, GSK163090, which is being developed for the treatment of depression and anxiety disorders.

Being tested
GSK163090
Keywords
163090, placebo-controlled, MDD, Depression, Tolerability, MDE
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

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

  • GSK163090Drug

What is being measured

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

  1. Safety and tolerability of GSK163090: Clinical laboratory, ECGs and vital signs assessments Questionnaire - DESS(Discontinuation Emergent Signs and symptoms)

    Measured: All over 10 days post dose for Group 1 and over 3 weeks for subjects in groups 2 and 3.

Secondary outcomes (1)

  1. •Questionnaires •Prolactin, cortisol •PK parameters for GSK163090

    Measured: All over 10 days post dose for Group 1 and over 3 weeks for subjects in groups 2 and 3.

Timeline

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

  1. First posted16 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559299
Sponsor's protocol ID
HTP110333
Status last verified
Feb 2011
First submitted
14 Nov 2007
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK163090 in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), 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 10 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 19 Mar 2012. 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?

Safety and tolerability of GSK163090: Clinical laboratory, ECGs and vital signs assessments Questionnaire - DESS(Discontinuation Emergent Signs and symptoms) (time frame: All over 10 days post dose for Group 1 and over 3 weeks for subjects in groups 2 and 3.). 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 NCT00559299.

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 19 Mar 2012.

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