NCT00488098

Brief Summary

The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
Last Updated

June 4, 2012

Status Verified

February 1, 2011

First QC Date

June 15, 2007

Last Update Submit

May 31, 2012

Conditions

Healthy SubjectsDepressive Disorder

Keywords

Healthy Bioequivalence

Outcome Measures

Primary Outcomes (1)

  • GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax

    at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.

Secondary Outcomes (3)

  • Adverse events

    all visits

  • vitals (all visits) + ECG

    at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.

  • labs

    at screening and 2 weeks post dose

Interventions

GSK372475DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Males/Females aged 18-45 years
  • Non-smokers
  • BMI 19-30 kg.m2
  • QTc\<450msec

You may not qualify if:

  • Use of oral contraception
  • Positive breath alcohol and drug screen
  • Regular alcohol consumption
  • Current psychiatric illness or within 1 year.
  • History of GI, hepatic or renal disease
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Toronto, Ontario, M1L 4S4, Canada

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

GSK372475

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 19, 2007

Study Start

July 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-02

Locations

CA(1)