VomitingPhase 1NCT00358813
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
A Phase 1 study testing Casopitant in people with Vomiting, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vomiting
- What is being tested?
- Casopitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2006to 22 Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have a peptic ulcer.
- Abuse drugs or alcohol.
- Are pregnant or lactating.
- Have heart failure.
- Have uncontrolled emesis.
- Have an infection.
Show all 10Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
Miramar, Florida, 33025
GSK Investigational Site
Orlando, Florida, 32809
About this study
Official title: 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.
- Conditions
- Vomiting
- Being tested
- Casopitant
- Keywords
- emesis, renal impairment, GW679769, kidney problems
- Medical subject headings
- Vomiting, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasopitantDrug
Also called GW679769
Casopitant oral tablets will be available with a dose of 50 milligrams.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving casopitant | Experimental | Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days. Receives: Drug: Casopitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: 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
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: 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 (11)
Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: 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
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: 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
Blood samples will be collected for assessment of protein binding of casopitant and GSK525060.
Measured: 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)
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.
Measured: Up to Day 22
Number of subjects with abnormal values for blood pressure
Systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Measured: Up to Day 22
Number of subjects with abnormal values for heart rate
Heart rate will be measured.
Measured: Up to Day 22
Number of subjects with abnormal findings after weight measurement
Weight evaluation will be performed as measure of safety.
Measured: Up to Day 22
Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Hematology parameters will be analyzed as a measure of safety.
Measured: Up to Day 22
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
Clinical chemistry parameters will be analyzed as a measure of safety.
Measured: Up to Day 22
Number of subjects having abnormal values for urinalysis as a measure of safety
Urinalysis will be carried out as a measure of safety.
Measured: Up to Day 22
Number of subjects with abnormal findings after serological tests
Serological tests will be performed as a measure of safety.
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study start8 Sep 2006
- Primary completion22 Aug 2008
- Study completion22 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358813
- Sponsor's protocol ID
- NKT102783
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2006
- Last updated
- 4 Aug 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment
- ClinicalTrials.gov ID
- NCT00358813
- Acronym / sponsor ID
- NKT102783
- Conditions
- Vomiting
- Keywords
- emesis, renal impairment, GW679769, kidney problems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2006 (actual)
- Primary completion
- 22 Aug 2008 (actual)
- Study completion
- 22 Aug 2008 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving casopitant | Experimental | Drug: CasopitantEligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Have a peptic ulcer.
- Abuse drugs or alcohol.
- Are pregnant or lactating.
- Have heart failure.
- Have uncontrolled emesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CasopitantAlso: GW679769Casopitant oral tablets will be available with a dose of 50 milligrams. | Drug | Subjects receiving casopitant |
Primary outcome
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.
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.
11 secondary outcomes
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
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
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
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 22
Number of subjects with abnormal values for blood pressure
Time frame: Up to Day 22
Number of subjects with abnormal values for heart rate
Time frame: Up to Day 22
Number of subjects with abnormal findings after weight measurement
Time frame: Up to Day 22
Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Time frame: Up to Day 22
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
Time frame: Up to Day 22
Number of subjects having abnormal values for urinalysis as a measure of safety
Time frame: Up to Day 22
Number of subjects with abnormal findings after serological tests
Time frame: Up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study NKT102783 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Casopitant in people with Vomiting, run by GlaxoSmithKline at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.