Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00460707
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
A Phase 1 study testing Casopitant 150 mg, Ketoconazole and Casopitant 50 mg in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human 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?
- Casopitant 150 mg, Ketoconazole and Casopitant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Apr 2007to 27 Aug 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
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ system functions.
- Able to swallow and retain oral medication.
- Subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Who cannot join
- Current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the study doctor, contraindicates participation.
- Use of an investigational drug within 28 days or 5 half-lives.
- Use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication.
- Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
- Iron deficiency.
Show all 19Show fewer
- Positive stool for occult blood.
- Female subject who is pregnant or lactating.
- Male subject who has a history of hypogonadism.
- Positive urine drug screen.
- Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen.
- Use of tobacco-containing products within the past 12 months prior to screening.
- History of drug or alcohol abuse or dependence within 6 months of screening.
- History or presence of uncontrolled emesis.
- Presence of active infection.
- History of cholecystectomy or biliary tract disease.
- Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
- Any degree of heart failure.
- Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pommelos or vegetables from the mustard green family within 7 days prior to the first dose unless prior approval is received.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Buffalo, New York, 14202
GSK Investigational Site
Columbus, Ohio, 43212
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant in Healthy Subjects
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.
- Being tested
- Casopitant 150 mg, Ketoconazole, Casopitant 150 mg matching placebo, Casopitant 50 mg, Casopitant 50 mg matching placebo
- Keywords
- GW679769, healthy adult subjects, casopitant, ketoconazole
- 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 150 mgDrug
Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
KetoconazoleDrug
Also called Casopitant
Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).
Casopitant 150 mg matching placeboDrug
Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
Casopitant 50 mgDrug
Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.
Casopitant 50 mg matching placeboDrug
Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | All subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2. Receives: Drug: Casopitant 150 mg; Drug: Ketoconazole; Drug: Casopitant 50 mg |
| Cohort 2, Group A | Placebo comparator | Subjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2. Receives: Drug: Ketoconazole; Drug: Casopitant 150 mg matching placebo; Drug: Casopitant 50 mg matching placebo |
| Cohort 2, Group B | Experimental | In treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2. Receives: Drug: Casopitant 150 mg; 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 of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1.
Measured: Day 4 to 9 in Cohort 1.
Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and
Measured: Day 2 to 4 of Period 1
casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2.
Measured: Day 4 to 9 of Period 2
Secondary outcomes (4)
Safety is evaluated in Cohort 1 by: - Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU)
Measured: at Screen, Day -1 & Followup (FU)
- Vitals Signs monitored at Screen, Day -1, 4-7 and FU
Measured: at Screen, Day -1, 4-7 and FU
- 12 lead ECGs at Screen & FU
Measured: at Screen & FU
- Adverse Events Monitoring starting at Day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study start16 Apr 2007
- Primary completion27 Aug 2007
- Study completion27 Aug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 85 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
- NCT00460707
- Sponsor's protocol ID
- NKV109990
- Status last verified
- Aug 2017
- First submitted
- 12 Apr 2007
- Last updated
- 3 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
Johnson BM, Adams LM, Zhang K, Gainer SD, Kirby LC, Blum RA, Apseloff G, Morrison RA, Schutz RA, Lebowitz PF. Ketoconazole and rifampin significantly affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1 receptor antagonist. J Clin Pharmacol. 2010 Aug;50(8):951-9. doi: 10.1177/0091270009353761. Epub 2010 Feb 2.
PubMed 20124517
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00460707
- Acronym / sponsor ID
- NKV109990
- Keywords
- GW679769, healthy adult subjects, casopitant, ketoconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2007 (actual)
- Primary completion
- 27 Aug 2007 (actual)
- Study completion
- 27 Aug 2007 (actual)
- First posted
- 16 Apr 2007 (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.
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Casopitant 150 mg, Drug: Ketoconazole, Drug: Casopitant 50 mgAll subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2. |
| Cohort 2, Group A | Placebo comparator | Drug: Ketoconazole, Drug: Casopitant 150 mg matching placebo, Drug: Casopitant 50 mg matching placeboSubjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2. |
| Cohort 2, Group B | Experimental | Drug: Casopitant 150 mg, Drug: Ketoconazole, Drug: Casopitant 50 mgIn treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ system functions.
- Able to swallow and retain oral medication.
- Subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Key exclusion criteria (19 listed)
- Current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the study doctor, contraindicates participation.
- Use of an investigational drug within 28 days or 5 half-lives.
- Use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication.
- Blood donation in excess of 500mL within 56 days prior to dosing 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 |
|---|---|---|
| Casopitant 150 mgCasopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach. | Drug | Cohort 1, Cohort 2, Group B |
| KetoconazoleAlso: CasopitantKetoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days). | Drug | Cohort 1, Cohort 2, Group A, Cohort 2, Group B |
| Casopitant 150 mg matching placeboCasopitant 150 mg matching placebo will be available as white, film-coated tablets. | Drug | Cohort 2, Group A |
| Casopitant 50 mgCasopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach. | Drug | Cohort 1, Cohort 2, Group B |
| Casopitant 50 mg matching placeboCasopitant 50 mg matching placebo will be available as pale orange, film-coated tablets. | Drug | Cohort 2, Group A |
Primary outcome
Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1.
Time frame: Day 4 to 9 in Cohort 1.
Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and
Time frame: Day 2 to 4 of Period 1
casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2.
Time frame: Day 4 to 9 of Period 2
4 secondary outcomes
Safety is evaluated in Cohort 1 by: - Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU)
Time frame: at Screen, Day -1 & Followup (FU)
- Vitals Signs monitored at Screen, Day -1, 4-7 and FU
Time frame: at Screen, Day -1, 4-7 and FU
- 12 lead ECGs at Screen & FU
Time frame: at Screen & FU
- Adverse Events Monitoring starting at Day 1
Time frame: Day 1
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 3 Aug 2017.
- Background: PubMed 20124517Johnson BM, Adams LM, Zhang K, Gainer SD, Kirby LC, Blum RA, Apseloff G, Morrison RA, Schutz RA, Lebowitz PF. Ketoconazole and rifampin significantly affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1 receptor antagonist. J Clin Pharmacol. 2010 Aug;50(8):951-9. doi: 10.1177/0091270009353761. Epub 2010 Feb 2.
- Results for study 109990 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.
Related trials for Nausea and Vomiting, Chemotherapy-Induced
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Active, not recruiting
Vomiting Prevention in Children With Cancer
Chemotherapy Induced Nausea and Vomiting, Quality of Life (QOL)
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 150 mg, Ketoconazole and Casopitant 50 mg in people with Nausea and Vomiting, Chemotherapy-Induced, 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 4 inclusion and 19 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 3 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. Some participants in this study may receive a placebo. 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 casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1. (time frame: Day 4 to 9 in Cohort 1.). The study lists 3 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 NCT00460707, 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 3 Aug 2017.