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

GlaxoSmithKline1 site in 1 country20 target enrollmentNovember 2007

ConditionsDepressive Disorder, Major Major Depressive Disorder (MDD)

DrugsGSK163090

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Depressive Disorder, Major
Sponsor: GlaxoSmithKline
Enrollment: 20
Locations: 1
Primary Endpoint: Safety and tolerability of GSK163090: Clinical laboratory, ECGs and vital signs assessments Questionnaire - DESS(Discontinuation Emergent Signs and symptoms)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

June 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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 \<
•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

•Questionnaires •Prolactin, cortisol •PK parameters for GSK163090(All over 10 days post dose for Group 1 and over 3 weeks for subjects in groups 2 and 3.)