Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00437229
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
A Phase 1 study testing Casopitant (GW679769) Oral Tablets, dexamethasone and ondansetron in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 1 site in United States.
Trial summary
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans. 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 (GW679769) Oral Tablets, dexamethasone and ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2007to 15 May 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 adult males or females
- Age: 18 to 55 years, inclusive
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ systems function
- Able to swallow and retain oral medication
- Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Who cannot join
- Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
- Use of an investigation drug within 28 days or 5 half-lives.
- 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.
- Presence of or suspected iron deficiency
- Positive stool for occult blood
Show all 13Show fewer
- Female subject who is lactating
- 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
- Positive purified protein derivative (PPD) skin test for tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
- Being tested
- Casopitant (GW679769) Oral Tablets, dexamethasone, ondansetron
- Keywords
- GW679769,, Casopitant,, Dexamethasone,, Healthy Human Volunteer, Ondansetron,
- 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 (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
dexamethasoneDrug
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
ondansetronDrug
Also called GW679769 Oral Tablets, dexamethasone oral tablets & intravenous, ondansetron oral tablets & intravenous
Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Subjects in Part A | Experimental | In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3). Receives: Drug: Casopitant (GW679769) Oral Tablets; Drug: dexamethasone; Drug: ondansetron |
| Subjects in Part B | Experimental | In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E. Receives: Drug: Casopitant (GW679769) Oral Tablets; Drug: dexamethasone; Drug: ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
Measured: checked on Day 1, 2 and/or 3
Secondary outcomes (3)
Safety is evaluated by: Clinical Lab Tests done
Measured: at Screening, Day -1 & Followup.
Vitals Signs taken & Adverse Events monitored
Measured: at each visit starting at Day -1.
12 lead ECGs & Serum Pepsinogen level tests
Measured: at Screening & Followup.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study start19 Feb 2007
- Primary completion15 May 2007
- Study completion15 May 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT00437229
- Sponsor's protocol ID
- NKV100787
- Status last verified
- Nov 2017
- First submitted
- 16 Feb 2007
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson B, Adams L, Lu E, Zhang K, Lebowitz P, Lates C, Blum R. Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone. Support Care Cancer. 2009 Sep;17(9):1177-85. doi: 10.1007/s00520-008-0571-5. Epub 2009 Feb 10.
PubMed 19205755
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00437229
- Acronym / sponsor ID
- NKV100787
- Keywords
- GW679769,, Casopitant,, Dexamethasone,, Healthy Human Volunteer, Ondansetron,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2007 (actual)
- Primary completion
- 15 May 2007 (actual)
- Study completion
- 15 May 2007 (actual)
- First posted
- 19 Feb 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.
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects in Part A | Experimental | Drug: Casopitant (GW679769) Oral Tablets, Drug: dexamethasone, Drug: ondansetronIn PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3). |
| Subjects in Part B | Experimental | Drug: Casopitant (GW679769) Oral Tablets, Drug: dexamethasone, Drug: ondansetronIn PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult males or females
- Age: 18 to 55 years, inclusive
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ systems function
- Able to swallow and retain oral medication
Key exclusion criteria (13 listed)
- Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
- Use of an investigation drug within 28 days or 5 half-lives.
- 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.
- Presence of or suspected iron deficiency
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 (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration. | Drug | Subjects in Part A, Subjects in Part B |
| dexamethasoneDexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration. | Drug | Subjects in Part A, Subjects in Part B |
| ondansetronAlso: GW679769 Oral Tablets, dexamethasone oral tablets & intravenous, ondansetron oral tablets & intravenousOndansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes. | Drug | Subjects in Part A, Subjects in Part B |
Primary outcome
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
Time frame: checked on Day 1, 2 and/or 3
3 secondary outcomes
Safety is evaluated by: Clinical Lab Tests done
Time frame: at Screening, Day -1 & Followup.
Vitals Signs taken & Adverse Events monitored
Time frame: at each visit starting at Day -1.
12 lead ECGs & Serum Pepsinogen level tests
Time frame: at Screening & Followup.
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 13 Nov 2017.
- Background: PubMed 19205755Johnson B, Adams L, Lu E, Zhang K, Lebowitz P, Lates C, Blum R. Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone. Support Care Cancer. 2009 Sep;17(9):1177-85. doi: 10.1007/s00520-008-0571-5. Epub 2009 Feb 10.
- Results for study 100787 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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
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 Casopitant (GW679769) Oral Tablets, dexamethasone and ondansetron 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 13 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 13 Nov 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?
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. (time frame: checked on Day 1, 2 and/or 3). 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 NCT00437229, 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 13 Nov 2017.