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Completed

NCT Number: NCT00358813

Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

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.

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Key information

Conditions

Vomiting Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Miramar, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

casopitant

Drug

Casopitant oral tablets will be available with a dose of 50 milligrams.

Other names: GW679769

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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