A Phase 1 interventional study of GW679769 in Vomiting, sponsored by GlaxoSmithKline. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 24 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.
Drug: GW679769
Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.
Drug: GW679769
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time to maximum observed concentration (tmax) of single oral dose of GW679769 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Time frame: 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
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Time frame: 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
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Time frame: 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 subjects with mild and moderate hepatic impairment
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Time frame: 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 GSK525060 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Time frame: 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 GSK525060 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Time frame: 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 GSK525060 in subjects with mild and moderate hepatic impairment
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Time frame: 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 GSK525060 in subjects with mild and moderate hepatic impairment
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Time frame: 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
Terminal half-life (t1/2) of single oral dose of GW679769 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Time frame: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of multiple oral dose of GW679769 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Time frame: 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
t1/2 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. t1/2 will be calculated from plasma GW679769 concentration-time data.
Time frame: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 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. t1/2 will be calculated from plasma GW679769 concentration-time data.
Time frame: 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
t1/2 of single oral dose of GSK525060 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data.
Time frame: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of multiple oral dose of GSK525060 in healthy subjects
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data.
Time frame: 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
t1/2 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. t1/2 will be calculated from plasma GSK525060 concentration-time data
Time frame: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 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. t1/2 will be calculated from plasma GSK525060 concentration-time data
Time frame: 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
Percentage of unbound GW679769 in healthy subjects receiving single oral dose of GW679769
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GW679769 in healthy subjects receiving multiple oral dose of GW679769
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving single oral dose of GW679769
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GW679769
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GSK525060 in healthy subjects receiving single oral dose of GSK525060
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GSK525060 in healthy subjects receiving multiple oral dose of GSK525060
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving single oral dose of GSK525060
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GSK525060
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
Time frame: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Number of subjects with Adverse events (AE) and Serious AEs (SAE)
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent disability/incapacity, or may led to any congenital anomaly or birth defect
Time frame: Up to Day 22
Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Blood pressure measurement will be assessed in supine and resting position.
Time frame: Up to Day 22
Number of subjects with abnormal heart rate
Blood pressure measurement will be assessed in supine and resting position.
Time frame: Up to Day 22
Number of subjects with abnormal hematology parameters
Laboratory assessment for hematology parameters will include hemoglobin, hematocrit, red blood cell count (RBC), platelet count, white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, prothrombin time (PT), and International Normalized Ratio (INR)
Time frame: Up to Day 22
Number of subjects with abnormal clinical chemistry parameters
Laboratory assessment for clinical chemistry parameters sodium, potassium, chloride, total Carbon dioxide, calcium, glucose (fasting), phosphorous (inorganic), protein (total), albumin, gamma-glutamyl-transferase (GGT), bilirubin (total), alkaline Phosphatase, lactic dehydrogenase (LDH), aspartate aminotransferase (AST; Serum glutamic oxaloacetic transaminase), alanine aminotransferase (ALT; Serum glutamic pyruvic transaminase), creatinine, blood Urea Nitrogen, uric Acid, creatine Phosphokinase (CPK), and ammonia
Time frame: Up to Day 22
Number of subjects with abnormal urinalysis
Laboratory assessment for urinalysis parameters pH, specific gravity, glucose, protein, ketones, and blood
Time frame: Up to Day 22
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline