A Placebo-controlled, Single-blind, Randomised, Parallel Group, 28-day Repeat Dose Study to Investigate the Tolerability, Safety and Steady State Pharmacokinetics of GSK372475 in Healthy Young and Elderly, Male and Female Subjects

GlaxoSmithKline1 site in 1 country66 target enrollmentJuly 28, 2008

ConditionsDepressive Disorder

InterventionsGSK372475

DrugsGSK372475

Overview

Phase: Phase 1
Intervention: GSK372475
Conditions: Depressive Disorder
Sponsor: GlaxoSmithKline
Enrollment: 66
Locations: 1
Primary Endpoint: Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo for 28 days.

Registry

clinicaltrials.gov

Start Date

July 28, 2008

End Date

December 29, 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy as determined by a responsible physician, based on a medical evaluation including medical and psychiatric history (including family history), full physical examination, laboratory tests and cardiac monitoring.
•Male or female between 18 and 45 years of age (young healthy population) and \>65 years old (elderly population).
•A female subject is eligible to participate if she is of:
•Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
•Child-bearing potential and agrees to use of specific contraception methods. Use of oral contraception is permitted.
•BMI within the range 19 - 29 kg/m2 (inclusive).
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
•Able to swallow and retain oral medication

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic (e.g. including but not limited to seizures, stroke, cerebrovascular disease or other brain conditions), or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing).
•Psychiatric illness currently or within the past year, or any lifetime history of bipolar disorder, major depressive disorder, anxiety disorder, schizophrenia or other psychotic disorder, or substance abuse or dependence (except past history of nicotine abuse/dependence).
•Subjects who, in the investigator's judgment, pose a suicidal or homicidal risk, or any subject with a history of suicidal or homicidal attempts or behaviour.
•The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).
•A positive test for HIV antibody.
•History of regular alcohol consumption within 6 months of the study defined as:
•an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
•The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 60 days i.e. 5 half-lives.

Arms & Interventions

GSK372475

Drug

Intervention: GSK372475

Outcomes

Primary Outcomes

Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.

Time Frame: pre-dose to 24 hours post dose

Secondary Outcomes

Safety and tolerability endpoints, including adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory tests.(from dosing to follow-up)