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Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358813
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Vomiting Drug: Casopitant Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Actual Study Start Date : September 8, 2006
Actual Primary Completion Date : August 22, 2008
Actual Study Completion Date : August 22, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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

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

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358813


Locations
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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
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Study Director: GSK Clinical Trials GlaxoSmithKline
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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358813    
Other Study ID Numbers: NKT102783
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 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.
Keywords provided by GlaxoSmithKline:
emesis
renal impairment
GW679769
kidney problems
Additional relevant MeSH terms:
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Renal Insufficiency
Vomiting
Signs and Symptoms, Digestive
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