- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358813
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
August 3, 2017 updated by: GlaxoSmithKline
An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miramar, Florida, United States, 33025
- GSK Investigational Site
-
Orlando, Florida, United States, 32809
- GSK Investigational Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects receiving casopitant
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
|
Casopitant oral tablets will be available with a dose of 50 milligrams.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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)
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.
|
Up to Day 22
|
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.
|
Up to Day 22
|
Number of subjects with abnormal values for heart rate
Time Frame: Up to Day 22
|
Heart rate will be measured.
|
Up to Day 22
|
Number of subjects with abnormal findings after weight measurement
Time Frame: Up to Day 22
|
Weight evaluation will be performed as measure of safety.
|
Up to Day 22
|
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.
|
Up to Day 22
|
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.
|
Up to Day 22
|
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.
|
Up to Day 22
|
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.
|
Up to Day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2006
Primary Completion (Actual)
August 22, 2008
Study Completion (Actual)
August 22, 2008
Study Registration Dates
First Submitted
July 28, 2006
First Submitted That Met QC Criteria
July 28, 2006
First Posted (Estimate)
August 1, 2006
Study Record Updates
Last Update Posted (Actual)
August 4, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Signs and Symptoms, Digestive
- Vomiting
- Renal Insufficiency
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Casopitant
Other Study ID Numbers
- NKT102783
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Study Data/Documents
-
Annotated Case Report Form
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: NKT102783Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vomiting
-
Instituto Materno Infantil Prof. Fernando FigueiraUniversidade Federal de PernambucoCompleted
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
Hoffmann-La RocheCompletedPost-Operative Nausea and VomitingUnited States
-
Cairo UniversityUnknownPost Operative Nausea and VomitingEgypt
-
Yonsei UniversityCompletedPost Operative Nausea and VomitingKorea, Republic of
-
AccentureCompletedPost-Operative Nausea and Vomiting (PONV)Australia
-
Oregon Health and Science UniversityCompletedPostoperative Vomiting and NauseaUnited States
-
Methodist Health SystemRecruitingNausea, Postoperative | Vomiting, PostoperativeUnited States
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Hungary, Canada, Spain, Belgium, Germany
Clinical Trials on Casopitant
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedUnited States
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedUnited States
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeSpain, United States, Philippines, Belgium, Hong Kong, Canada, Germany, Czech Republic, Thailand, Pakistan, Russian Federation
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedUnited States
-
GlaxoSmithKlineCompletedNausea and Vomiting, PostoperativeUnited States, Hong Kong, Ireland, France, Philippines, Germany, Hungary, Thailand, Canada, Pakistan, United Kingdom
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedUnited States
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedUnited States
-
GlaxoSmithKlineCompletedNausea and Vomiting, Chemotherapy-InducedFinland, Czechia, Argentina, Belgium, Philippines, Taiwan, Korea, Republic of, Bulgaria, Spain, Ireland, Thailand, Greece, Pakistan, Slovakia, Italy, Romania, Poland, Hungary, Ukraine, Croatia, Malaysia, India
-
GlaxoSmithKlineWithdrawnCancer | Solid Tumor Cancer | Chemotherapy-Induced Nausea and Vomiting | Nausea and VomitingUnited States, Canada
-
GlaxoSmithKlineCompletedNausea | Vomiting | Nausea and Vomiting, Chemotherapy-InducedUnited States, Germany, Bulgaria, Hungary, Philippines, Russian Federation, Taiwan, Korea, Republic of, Belgium, Denmark, Hong Kong, Slovakia, South Africa, Spain, Ireland, Latvia, Thailand, Italy, United Kingdom, Argentina, Aus... and more