Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00405080
A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).
A Phase 1 study testing GW679769 (Casopitant) oral tablets and Rifampin oral capsules in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Chemotherapy-Induced
- What is being tested?
- GW679769 (Casopitant) oral tablets and Rifampin oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2006to 5 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- female subjects who cannot become pregnant
- able to swallow and keep down oral medication
- can understand and follow the protocol requirements and instructions
Who cannot join
- smokes at least 4 packs per day in the past 12 months
- use of prescription or non-prescription drug(s)
- herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
- a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
- blood donation in excess of 1 pint within 56 days before dosing of medication
- iron deficient
Show all 16Show fewer
- history or drug allergy of study medication
- 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
- active peptic ulcer disease
- uncontrolled nausea and vomiting
- active infection
- heart failure
- female who is lactating
- female who has a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]
This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.
- Being tested
- GW679769 (Casopitant) oral tablets, Rifampin oral capsules
- Keywords
- Rifampin GW679769
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769 (Casopitant) oral tabletsDrug
Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
Rifampin oral capsulesDrug
Also called GW679769 (Casopitant) oral tablets
Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1 | Experimental | Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days. Receives: Drug: GW679769 (Casopitant) oral tablets |
| Treatment Period 2 | Experimental | Subjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin. Receives: Drug: GW679769 (Casopitant) oral tablets; Drug: Rifampin oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.
Measured: Up to Day 10
Secondary outcomes (1)
clinical lab tests adverse events vital signs 12 lead ECGs liver function tests
Measured: Up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study start11 Nov 2006
- Primary completion5 Jan 2007
- Study completion5 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT00405080
- Sponsor's protocol ID
- NKV105091
- Status last verified
- Sep 2017
- First submitted
- 27 Nov 2006
- Last updated
- 12 Sep 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 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]
- ClinicalTrials.gov ID
- NCT00405080
- Acronym / sponsor ID
- NKV105091
- Keywords
- Rifampin GW679769
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2006 (actual)
- Primary completion
- 5 Jan 2007 (actual)
- Study completion
- 5 Jan 2007 (actual)
- First posted
- 29 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.
This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1 | Experimental | Drug: GW679769 (Casopitant) oral tabletsSubject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days. |
| Treatment Period 2 | Experimental | Drug: GW679769 (Casopitant) oral tablets, Drug: Rifampin oral capsulesSubjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- female subjects who cannot become pregnant
- able to swallow and keep down oral medication
- can understand and follow the protocol requirements and instructions
Key exclusion criteria (16 listed)
- smokes at least 4 packs per day in the past 12 months
- use of prescription or non-prescription drug(s)
- herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
- a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
- blood donation in excess of 1 pint within 56 days before dosing of medication
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 |
|---|---|---|
| GW679769 (Casopitant) oral tabletsCasopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time. | Drug | Treatment Period 1, Treatment Period 2 |
| Rifampin oral capsulesAlso: GW679769 (Casopitant) oral tabletsRifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time. | Drug | Treatment Period 2 |
Primary outcome
Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.
Time frame: Up to Day 10
1 secondary outcome
clinical lab tests adverse events vital signs 12 lead ECGs liver function tests
Time frame: Up to Day 12
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 12 Sep 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 NKV105091 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW679769 (Casopitant) oral tablets and Rifampin oral capsules in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 1 site 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 4 inclusion and 16 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10. (time frame: Up to Day 10). 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 12 Sep 2017.