Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00404274
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
A Phase 1 study testing Casopitant (GW679769) oral tablets and Warfarin oral tablets in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Chemotherapy-Induced
- What is being tested?
- Casopitant (GW679769) oral tablets and Warfarin oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2006to 18 Mar 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- non-smoking
- Females cannot be able to have children
- Must be able to swallow and retain oral medication
- Understand and sign the written consent
- comply with the requirements and restrictions involved in an overnight 30 day confinement in a healthcare setting
Who cannot join
- cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- blood donation in excess of 1 pint within 56 days before dosing of medication
- iron deficiency
- history of drug or alcohol abuse or dependency within the past 6 months
- subjects cannot use any nicotine-containing products within the last 6 months
- positive for HIV, Hepatitis B or C
Show all 11Show fewer
- use of prescription or non-prescription drug(s), herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
- consumption of any food or drink containing grapefruit, Seville oranges, kumquats, pomelos (or their juices) within 7 days of the first dose of study medication
- history of bleeding disorders or excessive bleeding
- female who has a positive pregnancy test
- female who is lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Buffalo, New York, 14202
GSK Investigational Site
Gainesville, Florida, 32605
About this study
Official title: An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin When Co-administered With Repeat Doses of Casopitant [GW679769] in Healthy Adult Subjects.
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.
- Being tested
- Casopitant (GW679769) oral tablets, Warfarin oral tablets
- Keywords
- healthy human volunteer, GW679769, warfarin, casopitant
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casopitant (GW679769) oral tabletsDrug
Casopitant will be available in the dose strength of 20,30 or 50 mg
Warfarin oral tabletsDrug
Also called Casopitant (GW679769) oral tablets
Warfarin will be available in the dose strength of 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment regimen A | Experimental | In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day [mg/day], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin. Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets |
| Treatment regimen B | Experimental | In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days. Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets |
| Treatment regimen C | Experimental | In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days. Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
Measured: Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16.
Measured: Period 2: Day 2 & 3 and Day 5 to 16.
Secondary outcomes (1)
Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study start1 Nov 2006
- Primary completion18 Mar 2007
- Study completion18 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, Chemotherapy-InducedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 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
- NCT00404274
- Sponsor's protocol ID
- NKV105097
- Status last verified
- Aug 2017
- First submitted
- 27 Nov 2006
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- 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.
Publications
Kirby LC, Johnson BM, Adams LM, Eberwein DJ, Zhang K, Murray SC, Lates CD, Blum RA, Morris SR. Effect of casopitant, a novel NK-1 receptor antagonist, on the pharmacokinetics and pharmacodynamics of steady-state warfarin. J Clin Pharmacol. 2010 May;50(5):566-75. doi: 10.1177/0091270009346965. Epub 2010 Mar 10.
PubMed 20220045
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin When Co-administered With Repeat Doses of Casopitant [GW679769] in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT00404274
- Acronym / sponsor ID
- NKV105097
- Keywords
- healthy human volunteer, GW679769, warfarin, casopitant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 18 Mar 2007 (actual)
- Study completion
- 18 Mar 2007 (actual)
- First posted
- 28 Nov 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.
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment regimen A | Experimental | Drug: Casopitant (GW679769) oral tablets, Drug: Warfarin oral tabletsIn treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day [mg/day], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin. |
| Treatment regimen B | Experimental | Drug: Casopitant (GW679769) oral tablets, Drug: Warfarin oral tabletsIn treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days. |
| Treatment regimen C | Experimental | Drug: Casopitant (GW679769) oral tablets, Drug: Warfarin oral tabletsIn treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects
- non-smoking
- Females cannot be able to have children
- Must be able to swallow and retain oral medication
- Understand and sign the written consent
Key exclusion criteria (11 listed)
- cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- blood donation in excess of 1 pint within 56 days before dosing of medication
- iron deficiency
- history of drug or alcohol abuse or dependency within the past 6 months
- subjects cannot use any nicotine-containing products within the last 6 months
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 |
|---|---|---|
| Casopitant (GW679769) oral tabletsCasopitant will be available in the dose strength of 20,30 or 50 mg | Drug | Treatment regimen A, Treatment regimen B, Treatment regimen C |
| Warfarin oral tabletsAlso: Casopitant (GW679769) oral tabletsWarfarin will be available in the dose strength of 5 mg | Drug | Treatment regimen A, Treatment regimen B, Treatment regimen C |
Primary outcome
Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
Time frame: Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16.
Time frame: Period 2: Day 2 & 3 and Day 5 to 16.
1 secondary outcome
Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
Time frame: throughout the study
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 9 Aug 2017.
- Results publication: PubMed 20220045Kirby LC, Johnson BM, Adams LM, Eberwein DJ, Zhang K, Murray SC, Lates CD, Blum RA, Morris SR. Effect of casopitant, a novel NK-1 receptor antagonist, on the pharmacokinetics and pharmacodynamics of steady-state warfarin. J Clin Pharmacol. 2010 May;50(5):566-75. doi: 10.1177/0091270009346965. Epub 2010 Mar 10.
- 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 NKV105097 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
2 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 (GW679769) oral tablets and Warfarin oral tablets in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 2 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 6 inclusion and 11 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 9 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 2 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?
Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16. (time frame: Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.). 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?
On the ClinicalTrials.gov record for NCT00404274, which also lists 1 linked publication.
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 9 Aug 2017.