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Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358813
First received: July 28, 2006
Last updated: August 3, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Vomiting Drug: Casopitant Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060 [ Time Frame: 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 [ Time Frame: 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 Outcome Measures:
  • Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060 [ Time Frame: 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.

  • Half-life of casopitant and GSK525060 [ Time Frame: 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.

  • Free fraction (percent unbound) of casopitant and GSK525060 [ Time Frame: 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.

  • Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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 [ Time Frame: Up to Day 22 ]
    Systolic (SBP) and diastolic blood pressure (DBP) will be measured.

  • Number of subjects with abnormal values for heart rate [ Time Frame: Up to Day 22 ]
    Heart rate will be measured.

  • Number of subjects with abnormal findings after weight measurement [ Time Frame: Up to Day 22 ]
    Weight evaluation will be performed as measure of safety.

  • Number of subjects having abnormal hematology laboratory parameters as a measure of safety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to Day 22 ]
    Urinalysis will be carried out as a measure of safety.

  • Number of subjects with abnormal findings after serological tests [ Time Frame: Up to Day 22 ]
    Serological tests will be performed as a measure of safety.


Enrollment: 18
Actual Study Start Date: September 8, 2006
Study Completion Date: August 22, 2008
Primary Completion Date: August 22, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving casopitant
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
Drug: Casopitant
Casopitant oral tablets will be available with a dose of 50 milligrams.
Other Name: GW679769

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358813

Locations
United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: NKT102783
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358813     History of Changes
Other Study ID Numbers: NKT102783
Study First Received: July 28, 2006
Last Updated: August 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
emesis
renal impairment
GW679769
kidney problems

Additional relevant MeSH terms:
Vomiting
Renal Insufficiency
Signs and Symptoms, Digestive
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017