Chemotherapy-induced Nausea and VomitingPhase 1NCT02434861
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects
A Phase 1 study testing Rolapitant, Digoxin and Sulfasalazine in people with Chemotherapy-induced Nausea and Vomiting, run by Tesaro, Inc. at 1 site in United States.
Trial summary
The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population. 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, Digoxin and Sulfasalazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Aug 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
Main Inclusion Criteria:
- 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 Screening and on Day -1
- Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) before Visit 1 and to continue its use during the study and for at least 30 days after the final dose
- Subjects must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥50 kg at Screening
- Subjects must be capable of understanding the informed consent after the risks and benefits of the study have been explained; subjects must be able to sign a written informed consent and be willing to comply with the protocol requirements
- Subjects must be in general good health as determined by the Investigator based on pre-study medical and surgical history, physical examination [PE], and clinical laboratory tests
Main Exclusion Criteria:
- 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 the first study dose
- 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 units (450 mL) of blood, within 30 days before the first study dose
- Subjects who have a history of hypersensitivity to rolapitant IV or any of its excipients or who have participated in a previous rolapitant study within 6 months prior to administration of the first dose of study drug (Day 1)
- Subjects with poor venous access and/or cannot tolerate venipuncture
- Subjects with a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject
- Subjects who have a history of hypersensitivity to sulfasalazine (Part B only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (1.8 mg/mL Rolapitant IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) in Healthy Subjects
The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.
Read the detailed description
- Part A will compare the PK of oral digoxin alone and in combination with an IV infusion of rolapitant.
- Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral dose of sulfasalazine in combination with an IV infusion of rolapitant
- Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in combination with an IV infusion of rolapitant.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Rolapitant, Digoxin, Sulfasalazine, Cooperstown Cocktail
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RolapitantDrug
DigoxinDrug
P-gp substrate
SulfasalazineDrug
BCRP substrate
Cooperstown CocktailDrug
Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Rolapitant IV and Digoxin Receives: Drug: Rolapitant; Drug: Digoxin |
| Part B | Experimental | Rolapitant IV and Sulfasalazine Receives: Drug: Rolapitant; Drug: Sulfasalazine |
| Part C | Experimental | Rolapitant IV and Cooperstown Cocktail Receives: Drug: Rolapitant; Drug: Cooperstown Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC: area under the plasma concentration-time curve
To evaluate the effect of Rolapitant on the PK of probe substrates
Measured: Predose - up to 120 hours postdose
Cmax = observed maximum plasma concentration
To evaluate the effect of Rolapitant on the PK of probe substrates
Measured: Predose - up to 120 hours postdose
Secondary outcomes (1)
Number of participants with adverse events
To evaluate the safety and tolerability of combination administration of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and CYP probe substrates (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan [Cooperstown Cocktail]) with a single dose of rolapitant IV in a healthy adult population, as assessed by incidence and severity of AEs.
Measured: 0 - 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionAug 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT02434861
- Sponsor's protocol ID
- PR-11-5021-C
- Status last verified
- Aug 2015
- First submitted
- 30 Apr 2015
- 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, Single Dose, Three Part Study to Assess the Effects of Rolapitant (1.8 mg/mL Rolapitant IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02434861
- Acronym / sponsor ID
- PR-11-5021-C
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 May 2015 (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.
The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.
Detailed description
- Part A will compare the PK of oral digoxin alone and in combination with an IV infusion of rolapitant.
- Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral dose of sulfasalazine in combination with an IV infusion of rolapitant
- Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in combination with an IV infusion of rolapitant.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Rolapitant, Drug: DigoxinRolapitant IV and Digoxin |
| Part B | Experimental | Drug: Rolapitant, Drug: SulfasalazineRolapitant IV and Sulfasalazine |
| Part C | Experimental | Drug: Rolapitant, Drug: Cooperstown CocktailRolapitant IV and Cooperstown Cocktail |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 | Drug | Part A, Part B, Part C |
| DigoxinP-gp substrate | Drug | Part A |
| SulfasalazineBCRP substrate | Drug | Part B |
| Cooperstown CocktailMidazolam, omeprazole, warfarin, caffeine, and dextromethorphan | Drug | Part C |
Primary outcome
AUC: area under the plasma concentration-time curve
Time frame: Predose - up to 120 hours postdose
To evaluate the effect of Rolapitant on the PK of probe substrates
Cmax = observed maximum plasma concentration
Time frame: Predose - up to 120 hours postdose
To evaluate the effect of Rolapitant on the PK of probe substrates
1 secondary outcome
Number of participants with adverse events
Time frame: 0 - 38 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, Digoxin and Sulfasalazine 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?
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?
AUC: area under the plasma concentration-time curve (time frame: Predose - up to 120 hours postdose). 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 25 Aug 2015.