Last updated: 11/07/2018 17:46:12

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

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GSK study ID
NKT102785
See study documents
Clinicaltrials.gov ID
NCT00359177
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in subjects with Hepatic Impairment
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Secondary outcomes:
Not applicable
Interventions:
Drug: GW679769
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
John Bauman, Joyce Antal, Laurel Adams, Brendan Johnson, Sharon Murray, Bin Peng, Lyndon Kirby, Peter Lebovitz, Thomas Marbury, Suzanne Swan, Maria Gutierrez, Geraldine Bichier. Effect of Hepatic or Renal Impairment on the Pharmacokinetics of Casopitant, a NK-1 Receptor Antagonist, for the Prevention of Post-Operative or Chemotherapy-Induced Nausea and Vomiting. Invest New Drugs. 2012;30(2):662-671.
Medical condition
Vomiting
Product
casopitant
Collaborators
Not applicable
Study date(s)
December 2005 to October 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • 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)
  • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
  • Encephalopathy
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
Status
Study Complete
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Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-12-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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