Chemotherapy-induced Nausea and VomitingPhase 1NCT02285647
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
A Phase 1 study testing Rolapitant - Oral and Rolapitant - IV in people with Chemotherapy-induced Nausea and Vomiting, run by Tesaro, Inc. at 1 site in United States.
Trial summary
This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects. 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?
- Rolapitant - Oral and Rolapitant - IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- 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
- Subjects must be healthy males or females aged 18 to 55 years (inclusive).
- Female subjects of childbearing potential must have a negative pregnancy test at the Screening visit and on Day -1.
- Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from 72 hours before admission to the clinical unit until study completion.
- Subjects must have a BMI from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥ 50 kg at the Screening visit.
- Subjects must be able to provide informed consent after risks and benefits have been explained. Subjects must be capable of understanding, able to sign a written informed consent and willing to comply with the protocol requirements.
- Subjects must be non-tobacco users (defined as a subject who has not smoked or used nicotine products in the last 90 days before administration of study drug) and have a negative cotinine test for nicotine at the Screening visit and Day -1.
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- Subjects must agree to discontinue intake of alcohol and beverages or food known to interfere with CYP metabolic enzymes such as: grapefruit- and quinine-containing food and beverages (e.g., tonic water, bitter lemon), orange juice, prune juice, pomelos, cranberry, pomegranate, star fruit, Seville oranges (or marmalade made from them), garlic supplements, St. John's Wort or licorice from 72 hours before admission to the clinical unit until completion of the study.
- Subjects must be in general good health as determined by the Investigator, based on prestudy medical and surgical history, physical examination and clinical laboratory tests.
- Subjects must have cardiovascular (including 12-lead ECG) function at the Screening visit that has no clinically significant abnormalities as determined by the Investigator.
Who cannot join
- Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose.
- Subjects who have a history of hypersensitivity to rolapitant or any of its excipients or who have participated in a previous rolapitant study within 6 months before the time of first study drug dose administration dose (Day 1).
- Subjects who have a history of relevant allergies (including asthma, food or drug allergies), as determined by the Investigator.
- Subjects who have had significant blood loss, or have donated or received 1 or more units (450 mL) of blood within 30 days before the first study dose.
- Subjects who have received any prescription medications or over-the-counter (OTC) medications or herbal supplements within 14 days before the first study dose. By exception, acetaminophen ≤ 1 g/day is permitted.
- Subjects who have current or recent (within 1 year of the Screening visit) history of alcohol abuse, illicit drug use, physical dependence or addiction to alcohol or any opioid.
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- Cholecystectomized subjects (since biliary excretion is a predominant mode of excretion with rolapitant).
- Subjects who have any clinical or psychiatric condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
- Subjects who are unwilling or unable to avoid xanthine- and caffeine-containing drinks (including many soft drinks, energy drinks, coffee and tea) and foods (such as chocolate or coffee flavored) from 72 hours before admission through until the subjects are discharged on Day 39.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.
Read the detailed description
To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Rolapitant - Oral, Rolapitant - IV
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rolapitant - OralDrug
Also called Rolapitant
Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)
Rolapitant - IVDrug
Also called Rolapitant
IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)
| Study group | Role | What they receive |
|---|---|---|
| Rolapitant - Oral | Experimental | Investigational Product: Rolapitant Dose: 200 mg (4 x 50mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) Receives: Drug: Rolapitant - Oral |
| Rolapitant - IV | Experimental | Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) Receives: Drug: Rolapitant - IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: 39-69 days
Secondary outcomes (1)
Cmax: observed maximum plasma concentration
Measured: 39-69 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Vargo, MD, Study director, Tesaro, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285647
- Sponsor's protocol ID
- PR-11-5016-C
- Status last verified
- Aug 2015
- First submitted
- 25 Sep 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
- ClinicalTrials.gov ID
- NCT02285647
- Acronym / sponsor ID
- PR-11-5016-C
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Nov 2014 (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 an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.
Detailed description
To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rolapitant - Oral | Experimental | Drug: Rolapitant - OralInvestigational Product: Rolapitant Dose: 200 mg (4 x 50mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) |
| Rolapitant - IV | Experimental | Drug: Rolapitant - IVInvestigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must be healthy males or females aged 18 to 55 years (inclusive).
- Female subjects of childbearing potential must have a negative pregnancy test at the Screening visit and on Day -1.
- Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from 72 hours before admission to the clinical unit until study completion.
- Subjects must have a BMI from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥ 50 kg at the Screening visit.
- Subjects must be able to provide informed consent after risks and benefits have been explained. Subjects must be capable of understanding, able to sign a written informed consent and willing to comply with the protocol requirements.
Key exclusion criteria (9 listed)
- Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose.
- Subjects who have a history of hypersensitivity to rolapitant or any of its excipients or who have participated in a previous rolapitant study within 6 months before the time of first study drug dose administration dose (Day 1).
- Subjects who have a history of relevant allergies (including asthma, food or drug allergies), as determined by the Investigator.
- Subjects who have had significant blood loss, or have donated or received 1 or more units (450 mL) of blood within 30 days before the first study dose.
- Subjects who have received any prescription medications or over-the-counter (OTC) medications or herbal supplements within 14 days before the first study dose. By exception, acetaminophen ≤ 1 g/day is permitted.
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 |
|---|---|---|
| Rolapitant - OralAlso: RolapitantOral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) | Drug | Rolapitant - Oral |
| Rolapitant - IVAlso: RolapitantIV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) | Drug | Rolapitant - IV |
Primary outcome
AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: 39-69 days
1 secondary outcome
Cmax: observed maximum plasma concentration
Time frame: 39-69 days
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 25 Aug 2015.
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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.
Dennis Vargo, MD study director
Tesaro, Inc.
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 Rolapitant - Oral and Rolapitant - IV in people with Chemotherapy-induced Nausea and Vomiting, run by Tesaro, Inc. 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 9 inclusion and 9 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 25 Aug 2015. 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?
AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (time frame: 39-69 days). 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 25 Aug 2015.