NCT00359177

Brief Summary

The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

2 active sites

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

December 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2006

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

July 28, 2006

Last Update Submit

September 21, 2017

Conditions

Vomiting

Keywords

emesis liver problems hepatic impairment GW679769

Outcome Measures

Primary Outcomes (16)

  • Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects

    Blood samples for pharmacokinetics (PK) analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • AUC of multiple oral dose of GW679769 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • Cmax of multiple oral dose of GW679769 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • AUC of single oral dose of GSK525060 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • AUC of multiple oral dose of GSK525060 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • Cmax of single oral dose of GSK525060 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • Cmax of multiple oral dose of GSK525060 in healthy subjects

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

    Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Other Outcomes (30)

  • Time to maximum observed concentration (tmax) of single oral dose of GW679769 in healthy subjects

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • tmax of multiple oral dose of GW679769 in healthy subjects

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

  • tmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

    Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

  • +27 more other outcomes

Study Arms (2)

Healthy subjects receiving GW679769

EXPERIMENTAL

Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.

Drug: GW679769

Subjects with hepatic impairment receiving GW679769

EXPERIMENTAL

Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.

Drug: GW679769

Interventions

GW679769DRUG

GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning

Healthy subjects receiving GW679769Subjects with hepatic impairment receiving GW679769

Eligibility Criteria

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

You may qualify if:

  • Healthy or have mild or moderate hepatic impairment
  • Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
  • Negative for Hepatitis B and C(healthy subjects)
  • Negative drug, alcohol and HIV tests

You may not qualify if:

  • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
  • Encephalopathy
  • Active peptic ulcer disease
  • Drug or alcohol abuse
  • Pregnant or lactating
  • Esophageal bleeding
  • Heart failure
  • Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Gainesville, Florida, 32608, United States

Location

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

Related Links

MeSH Terms

Conditions

Vomiting

Interventions

casopitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

December 1, 2005

Primary Completion

October 12, 2006

Study Completion

October 12, 2006

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Annotated Case Report Form (NKT102785)Access
Statistical Analysis Plan (NKT102785)Access
Dataset Specification (NKT102785)Access
Study Protocol (NKT102785)Access
Clinical Study Report (NKT102785)Access
Informed Consent Form (NKT102785)Access
Individual Participant Data Set (NKT102785)Access

Locations

US(2)