Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00404378
Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]
A Phase 1 study testing ketoconazole, casopitant 100 mg and Casopitant 50 mg in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. 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?
- ketoconazole, casopitant 100 mg and Casopitant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 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 male or females
- Females must be of non-childbearing potential
- Adequate organ functions
- Able to swallow and retain oral medications
- Able to understand and comply with study requirements
- Signed ICF
Who cannot join
- Clinically relevant abnormality identified on the screening exam or any other medical condition or circumstance making the subject unsuitable for participation in the study.
- History of drug or other allergy which contraindicates participation.
- Known immediate hypersensitivity reaction or idiosyncrasy to GW679769 or ketoconazole or drugs chemically related to the study medications.
- Use of an investigational drug within 28 days preceding the first dose of GW679769 or ketoconazole or participation in another clinical trial within the past 30 days.
- Blood donation in excess of 1 pint within 56 days prior to first dose of study medication or intends to donate within 30 days of the post-treatment follow-up visit.
- History of or suspected iron deficiency.
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- Positive stool for occult blood.
- Pepsinogen level below the lower limit of laboratory reference range (LLRR).
- Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test.
- For male subjects, any history of hypogonadism and treatments associated with hypogonadism including radiation therapy to the testicles.
- For female subjects, a positive serum ß-hCG (beta-human chorionic gonadotropin) pregnancy test.
- Female subject who is lactating.
- Positive urine drug screen (UDS) including alcohol.
- Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
- Positive urinary cotinine. Subjects must not have used any nicotine-containing products, including nicotine patches or gum, within the past 6 months.
- Smoking history = 4 packs per day/year or smoked within the past 12 months.
- History of drug abuse or dependence within the past 6 months.
- History of alcohol abuse within the past 6 months or alcohol consumption in the past 6 months exceeding study requirements
- Presence of uncontrolled nausea \& vomiting.
- Presence of an active infection.
- Any degree of heart failure as defined by the New York Heart Association functional classification system.
- Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
- Use of any prescription or non-prescription drug(s), herbal or dietary supplements or vitamins within 14 days prior to the first dose of study medication.
- Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pomelos or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi and brussels sprouts, mustard) within 14 days prior to the first dose of study medication.
- History of cholecystectomy or biliary tract disease.
- Any serious or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
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 Ketoconazole on the Pharmacokinetics of a Single Oral Dose of [GW679769]
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.
- Being tested
- ketoconazole, casopitant 100 mg, Casopitant 50 mg
- Keywords
- Healthy subjects, Pharmacokinetics, Drug interaction, Ketoconazole, 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.
ketoconazoleDrug
Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
casopitant 100 mgDrug
Also called casopitant, ketoconazole
Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time
Casopitant 50 mgDrug
Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Treatment Period 1 | Experimental | Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days. Receives: Drug: casopitant 100 mg |
| Cohort 1 Treatment Period 2 | Experimental | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole. Receives: Drug: ketoconazole; Drug: casopitant 100 mg |
| Cohort 2 Treatment Period 1 | Experimental | Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days. Receives: Drug: Casopitant 50 mg |
| Cohort 2 Treatment Period 2 | Experimental | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole. Receives: Drug: ketoconazole; Drug: Casopitant 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3.
Measured: Period 1: Day 1, 2 & 3
Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8.
Measured: Period 2: Day 4, 5, 6, 7, & 8.
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 start20 Oct 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
- 15 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
- NCT00404378
- Sponsor's protocol ID
- NKV105093
- Status last verified
- Sep 2017
- First submitted
- 27 Nov 2006
- Last updated
- 12 Sep 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.
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 Ketoconazole on the Pharmacokinetics of a Single Oral Dose of [GW679769]
- ClinicalTrials.gov ID
- NCT00404378
- Acronym / sponsor ID
- NKV105093
- Keywords
- Healthy subjects, Pharmacokinetics, Drug interaction, Ketoconazole, Casopitant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2006 (actual)
- Primary completion
- 5 Jan 2007 (actual)
- Study completion
- 5 Jan 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.
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Treatment Period 1 | Experimental | Drug: casopitant 100 mgSubjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days. |
| Cohort 1 Treatment Period 2 | Experimental | Drug: ketoconazole, Drug: casopitant 100 mgSubjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole. |
| Cohort 2 Treatment Period 1 | Experimental | Drug: Casopitant 50 mgSubjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days. |
| Cohort 2 Treatment Period 2 | Experimental | Drug: ketoconazole, Drug: Casopitant 50 mgSubjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or females
- Females must be of non-childbearing potential
- Adequate organ functions
- Able to swallow and retain oral medications
- Able to understand and comply with study requirements
Key exclusion criteria (26 listed)
- Clinically relevant abnormality identified on the screening exam or any other medical condition or circumstance making the subject unsuitable for participation in the study.
- History of drug or other allergy which contraindicates participation.
- Known immediate hypersensitivity reaction or idiosyncrasy to GW679769 or ketoconazole or drugs chemically related to the study medications.
- Use of an investigational drug within 28 days preceding the first dose of GW679769 or ketoconazole or participation in another clinical trial within the past 30 days.
- Blood donation in excess of 1 pint within 56 days prior to first dose of study medication or intends to donate within 30 days of the post-treatment follow-up visit.
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 |
|---|---|---|
| ketoconazoleKetoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time. | Drug | Cohort 1 Treatment Period 2, Cohort 2 Treatment Period 2 |
| casopitant 100 mgAlso: casopitant, ketoconazoleCasopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time | Drug | Cohort 1 Treatment Period 1, Cohort 1 Treatment Period 2 |
| Casopitant 50 mgCasopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time. | Drug | Cohort 2 Treatment Period 1, Cohort 2 Treatment Period 2 |
Primary outcome
Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3.
Time frame: Period 1: Day 1, 2 & 3
Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8.
Time frame: Period 2: Day 4, 5, 6, 7, & 8.
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 12 Sep 2017.
- Results for study NKV105093 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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 ketoconazole, casopitant 100 mg and Casopitant 50 mg 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 6 inclusion and 26 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 will be measured for casopitant at Period 1: Day 1, 2 & 3. (time frame: Period 1: Day 1, 2 & 3). 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 12 Sep 2017.