Vomiting
Conditions
Keywords
emesis, renal impairment, GW679769, kidney problems
Brief summary
The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
Interventions
DRUGCasopitant
Casopitant oral tablets will be available with a dose of 50 milligrams.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy or have mild or moderate renal impairment. * Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner). * Be negative for Hepatitis B and C. * Have negative results on drug, alcohol and HIV tests. * Have stable renal function.
Exclusion criteria
* Have a peptic ulcer. * Abuse drugs or alcohol. * Are pregnant or lactating. * Have heart failure. * Have uncontrolled emesis. * Have an infection. * Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start. * Active peptic ulcer disease. * Digoxin use. * Laboratory results that show low iron or pepsinogen levels, AST and CK level \>1,5 ULN, or that show stool is positive for occult blood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis. |
| Maximum observed concentration (Cmax) of casopitant and GSK525060 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis. |
| Number of subjects with adverse events (AEs) and serious adverse events (SAEs) | Up to Day 22 | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. |
| Number of subjects with abnormal values for blood pressure | Up to Day 22 | Systolic (SBP) and diastolic blood pressure (DBP) will be measured. |
| Number of subjects with abnormal values for heart rate | Up to Day 22 | Heart rate will be measured. |
| Half-life of casopitant and GSK525060 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis. |
| Number of subjects having abnormal hematology laboratory parameters as a measure of safety | Up to Day 22 | Hematology parameters will be analyzed as a measure of safety. |
| Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety | Up to Day 22 | Clinical chemistry parameters will be analyzed as a measure of safety. |
| Number of subjects having abnormal values for urinalysis as a measure of safety | Up to Day 22 | Urinalysis will be carried out as a measure of safety. |
| Number of subjects with abnormal findings after serological tests | Up to Day 22 | Serological tests will be performed as a measure of safety. |
| Number of subjects with abnormal findings after weight measurement | Up to Day 22 | Weight evaluation will be performed as measure of safety. |
| Free fraction (percent unbound) of casopitant and GSK525060 | 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5 | Blood samples will be collected for assessment of protein binding of casopitant and GSK525060. |
Countries
United States
Outcome results
None listed