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Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359177
First received: July 28, 2006
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
The purpose of the study is to evaluate how subjects with mild or moderate liver 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 Hepatic Impairment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Enrollment: 24
Study Start Date: December 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy or have mild or moderate hepatic impairment
  • Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
  • Negative for Hepatitis B and C(healthy subjects)
  • Negative drug, alcohol and HIV tests

Exclusion criteria:

  • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
  • Encephalopathy
  • Active peptic ulcer disease
  • Drug or alcohol abuse
  • Pregnant or lactating
  • Esophageal bleeding
  • Heart failure
  • Infection
  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: NCT00359177

Locations
United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32608
GSK Investigational Site
Orlando, Florida, United States, 32809
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: NKT102785
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: NKT102785
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: NKT102785
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NKT102785
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: NKT102785
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: NKT102785
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: NKT102785
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359177     History of Changes
Other Study ID Numbers: NKT102785
Study First Received: July 28, 2006
Last Updated: October 20, 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 liver problems hepatic impairment GW679769

Additional relevant MeSH terms:
Vomiting
Liver Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System 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 April 26, 2017