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Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Nausea and Vomiting
  • Vomiting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC of multiple oral dose of GSK525060 in healthy subjects
AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
AUC of multiple oral dose of GW679769 in healthy subjects
+13 more
Other study objectives
Number of subjects with Adverse events (AE) and Serious AEs (SAE)
Number of subjects with abnormal clinical chemistry parameters
Number of subjects with abnormal heart rate
+26 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with hepatic impairment receiving GW679769Experimental Treatment1 Intervention
Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.
Group II: Healthy subjects receiving GW679769Experimental Treatment1 Intervention
Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Casopitant
Not yet FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,166 Total Patients Enrolled
2 Trials studying Nausea and Vomiting
492 Patients Enrolled for Nausea and Vomiting
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,535 Total Patients Enrolled
1 Trials studying Nausea and Vomiting
~1 spots leftby Jan 2026
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