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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: November 4, 2016
Last verified: November 2016
  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: GW679769
Phase 1

Study Type: Interventional
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:

Enrollment: 18
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  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: November 4, 2016
Individual Participant Data  
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:
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 March 29, 2017