Chemotherapy-induced Nausea and VomitingPhase 1NCT03245918
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers
A Phase 1 study testing Aprepitant Capsule 125 MG and Aprepitant oral suspension 20 mg/mL in people with Chemotherapy-induced Nausea and Vomiting, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Aprepitant Capsule 125 MG and Aprepitant oral suspension 20 mg/mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2017to 5 Jan 2018
- 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 female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests)
- 18 to 55 years of age
- BMI within 18.5 to 30 kg/m2
- Non-smoker
- Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, and heart rate between 60-100 bpm, inclusive.
- Female subjects of childbearing potential should be either sexually inactive (abstinent) or be using one of acceptable methods of birth control for 15 days prior to the first dose of the study, throughout the study and for at least 30 days after the last aprepitant dose.
- Able to swallow whole aprepitant capsules
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer.
Who cannot join
- Clinically significant illness or surgery within 8 weeks prior to dosing.
- Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.
- History of allergic reactions to the study drug and/or its excipients.
- Subjects concurrently treated with drugs that are metabolized through CYP3A4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc.
- History of drug or alcohol abuse within the last 6 months.
- Severe mental disorders.
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- Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
- Pregnant or breastfeeding.
- Use of recreational drugs, prescription medications (other than hormonal contraceptive agents),non-prescription medications (over-the-counter) or natural health products within 7 days or 5 half-lives (whichever is longer) prior to the administration of the first dose of study medication.
- Consumed grapefruit or grapefruit products within 7 days of each study period
- Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Aprepitant Capsule 125 MG, Aprepitant oral suspension 20 mg/mL
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant Capsule 125 MGDrug
Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
Aprepitant oral suspension 20 mg/mLDrug
Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant Capsule Study Period #1 | Other | Not described Receives: Drug: Aprepitant Capsule 125 MG |
| Aprepitant Oral Suspension Study Period#1 | Other | Not described Receives: Drug: Aprepitant oral suspension 20 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of the oral suspension relative to the capsule
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start10 Aug 2017
- Primary completion31 Dec 2017
- Study completion5 Jan 2018
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 Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Dupuis, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245918
- Sponsor's protocol ID
- 1000056100
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2017
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel P, Nathan PC, Walker SE, Zupanec S, Volpe J, Dupuis LL. Relative bioavailability of an extemporaneously prepared aprepitant oral suspension in healthy adults. J Oncol Pharm Pract. 2019 Dec;25(8):1907-1915. doi: 10.1177/1078155219828806. Epub 2019 Feb 5.
PubMed 31694495
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03245918
- Acronym / sponsor ID
- 1000056100
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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.
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant Capsule Study Period #1 | Other | Drug: Aprepitant Capsule 125 MG |
| Aprepitant Oral Suspension Study Period#1 | Other | Drug: Aprepitant oral suspension 20 mg/mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests)
- 18 to 55 years of age
- BMI within 18.5 to 30 kg/m2
- Non-smoker
- Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, and heart rate between 60-100 bpm, inclusive.
Key exclusion criteria (11 listed)
- Clinically significant illness or surgery within 8 weeks prior to dosing.
- Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.
- History of allergic reactions to the study drug and/or its excipients.
- Subjects concurrently treated with drugs that are metabolized through CYP3A4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc.
- History of drug or alcohol abuse 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 |
|---|---|---|
| Aprepitant Capsule 125 MGPatients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period | Drug | Aprepitant Capsule Study Period #1 |
| Aprepitant oral suspension 20 mg/mLPatients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period | Drug | Aprepitant Oral Suspension Study Period#1 |
Primary outcome
Bioavailability of the oral suspension relative to the capsule
Time frame: 6 weeks
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 11 Apr 2022.
- Results publication: PubMed 31694495Patel P, Nathan PC, Walker SE, Zupanec S, Volpe J, Dupuis LL. Relative bioavailability of an extemporaneously prepared aprepitant oral suspension in healthy adults. J Oncol Pharm Pract. 2019 Dec;25(8):1907-1915. doi: 10.1177/1078155219828806. Epub 2019 Feb 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aprepitant Capsule 125 MG and Aprepitant oral suspension 20 mg/mL in people with Chemotherapy-induced Nausea and Vomiting, run by The Hospital for Sick Children at 1 site in Canada.
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 8 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 11 Apr 2022. 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 Canada. 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?
Bioavailability of the oral suspension relative to the capsule (time frame: 6 weeks). 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 NCT03245918, 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 11 Apr 2022.