Last updated: 11/07/2018 17:45:56

Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

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GSK study ID
NKT102783
See study documents
Clinicaltrials.gov ID
NCT00358813
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 Renal Impairment
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060

Timeframe: 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

Maximum observed concentration (Cmax) of casopitant and GSK525060

Timeframe: 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

Secondary outcomes:

Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060

Timeframe: 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

Half-life of casopitant and GSK525060

Timeframe: 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

Free fraction (percent unbound) of casopitant and GSK525060

Timeframe: 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5

Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Day 22

Number of subjects with abnormal values for blood pressure

Timeframe: Up to Day 22

Number of subjects with abnormal values for heart rate

Timeframe: Up to Day 22

Number of subjects with abnormal findings after weight measurement

Timeframe: Up to Day 22

Number of subjects having abnormal hematology laboratory parameters as a measure of safety

Timeframe: Up to Day 22

Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety

Timeframe: Up to Day 22

Number of subjects having abnormal values for urinalysis as a measure of safety

Timeframe: Up to Day 22

Number of subjects with abnormal findings after serological tests

Timeframe: Up to Day 22

Interventions:
Drug: Casopitant
Enrollment:
18
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)
September 2006 to August 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
Yes
  • 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).
  • Have a peptic ulcer.
  • Abuse drugs or alcohol.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
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Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Study Complete
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Location
GSK Investigational Site
Miramar, Florida, United States, 33025
Status
Study Complete
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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
2008-22-08

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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Additional information
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