NCT00833391

Brief Summary

The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 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

Study Start

First participant enrolled

January 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 14, 2013

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

January 29, 2009

Last Update Submit

May 10, 2013

Conditions

PharmacokineticsHealthy Volunteer

Keywords

healthy volunteerformulationsbioavailabilitypharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • gabapentin concentrations in blood

    measured up to 36 hr after dosing

Secondary Outcomes (2)

  • gabapentin concentrations in urine

    measured up to 36 hr after dosing

  • Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.

    throughout the study

Study Arms (1)

GSK1838262 arm

EXPERIMENTAL

Each subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence.

Drug: open label

Interventions

open labelDRUG

This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.

GSK1838262 arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy, male and female subjects aged between 18 and 65 years old.
  • normal body weight.
  • normal ECG, vital signs and lab tests.
  • normal kidney function
  • agree to use acceptable contraceptive methods required.
  • capable of giving written informed consent.

You may not qualify if:

  • positive blood alcohol or urine drug test.
  • positive hepatitis B/C and HIV
  • donation of more than 450 mL blood within the 56 days.
  • sensitivity to gabapentin
  • pregnant or lactating females
  • smoker
  • certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
  • history of seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Evansville, Indiana, 47710, United States

Location

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 2, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 14, 2013

Record last verified: 2010-03

Locations

US(1)