Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

Vomiting Clinical Trial

Official title:

An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358813
• Other study ID #: NKT102783
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2006
• Last updated: August 3, 2017
• Start date: September 8, 2006
• Est. completion date: August 22, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 22, 2008
• Est. primary completion date: August 22, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Vomiting

Intervention

Drug:
• Casopitant
Casopitant oral tablets will be available with a dose of 50 milligrams.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Miramar	Florida
United States	GSK Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060	Blood samples will be collected at the indicated time points for pharmacokinetic analysis.	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
Primary	Maximum observed concentration (Cmax) of casopitant and GSK525060	Blood samples will be collected at the indicated time points for pharmacokinetic analysis.	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
Secondary	Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060	Blood samples will be collected at the indicated time points for pharmacokinetic analysis.	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
Secondary	Half-life of casopitant and GSK525060	Blood samples will be collected at the indicated time points for pharmacokinetic analysis.	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
Secondary	Free fraction (percent unbound) of casopitant and GSK525060	Blood samples will be collected for assessment of protein binding 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
Secondary	Number of subjects with adverse events (AEs) and serious adverse events (SAEs)	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.	Up to Day 22
Secondary	Number of subjects with abnormal values for blood pressure	Systolic (SBP) and diastolic blood pressure (DBP) will be measured.	Up to Day 22
Secondary	Number of subjects with abnormal values for heart rate	Heart rate will be measured.	Up to Day 22
Secondary	Number of subjects with abnormal findings after weight measurement	Weight evaluation will be performed as measure of safety.	Up to Day 22
Secondary	Number of subjects having abnormal hematology laboratory parameters as a measure of safety	Hematology parameters will be analyzed as a measure of safety.	Up to Day 22
Secondary	Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety	Clinical chemistry parameters will be analyzed as a measure of safety.	Up to Day 22
Secondary	Number of subjects having abnormal values for urinalysis as a measure of safety	Urinalysis will be carried out as a measure of safety.	Up to Day 22
Secondary	Number of subjects with abnormal findings after serological tests	Serological tests will be performed as a measure of safety.	Up to Day 22

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study NKT102783 can be found on the GSK Clinical Study Register.