Healthy AdultsPhase 1NCT04800614
A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
A Phase 1 study testing sitravatinib in people with Healthy Adults, run by Mirati Therapeutics Inc. at 1 site in United States.
Trial summary
An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- sitravatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 28 Mar 2022
- 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
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in
- Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception
- Male subjects must agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Who cannot join
- History of drug/chemical abuse within 2 years prior to screening.
- History of alcohol abuse within 12 months prior to screening
- Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
- Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period 1.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.
- Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Dallas, Texas, 75247
About this study
Official title: An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
- Conditions
- Healthy Adults
- Being tested
- sitravatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitravatinibDrug
100 mg sitravatinib on Day 1 of each of 3 periods
| Study group | Role | What they receive |
|---|---|---|
| Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal) | Experimental | Dosing in the fasted state followed by fed dosing after high and low fat meals Receives: Drug: sitravatinib |
| Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal) | Experimental | Dosing in the fasted state followed by fed dosing after low and high fat meals Receives: Drug: sitravatinib |
| Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal) | Experimental | Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal Receives: Drug: sitravatinib |
| Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state | Experimental | Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state Receives: Drug: sitravatinib |
| Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat) | Experimental | Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal) Receives: Drug: sitravatinib |
| Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state | Experimental | Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state Receives: Drug: sitravatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax (sitravatinib)
Maximum observed plasma concentration
Measured: Up to 72 hours after dosing
Pharmacokinetics - AUC∞ (sitravatinib)
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 72 hours after dosing
Pharmacokinetics - AUClast (sitravatinib)
AUC from time zero to the last measured time point
Measured: Up to 72 hours after dosing
Secondary outcomes (1)
Adverse Events (AEs)
Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects
Measured: Up to 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021
- Primary completion6 Jul 2021
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three Period Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curtis Chin, MD, Study director, Mirati Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800614
- Sponsor's protocol ID
- 516-009
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04800614
- Acronym / sponsor ID
- 516-009
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 16 Mar 2021 (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.
An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Three Period Crossover
| Arm | Type | Receives |
|---|---|---|
| Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal) | Experimental | Drug: sitravatinibDosing in the fasted state followed by fed dosing after high and low fat meals |
| Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal) | Experimental | Drug: sitravatinibDosing in the fasted state followed by fed dosing after low and high fat meals |
| Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal) | Experimental | Drug: sitravatinibDosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal |
| Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state | Experimental | Drug: sitravatinibFed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state |
| Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat) | Experimental | Drug: sitravatinibFed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal) |
| Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state | Experimental | Drug: sitravatinibFed dosing after a low-fat and high-fate meals followed by dosing in the fasted state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in
- Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception
- Male subjects must agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Key exclusion criteria (7 listed)
- History of drug/chemical abuse within 2 years prior to screening.
- History of alcohol abuse within 12 months prior to screening
- Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
- Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period 1.
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 |
|---|---|---|
| sitravatinib100 mg sitravatinib on Day 1 of each of 3 periods | Drug | Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal), Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal), Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal), Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state, Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state, Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat) |
Primary outcome
Pharmacokinetics - Cmax (sitravatinib)
Time frame: Up to 72 hours after dosing
Maximum observed plasma concentration
Pharmacokinetics - AUC∞ (sitravatinib)
Time frame: Up to 72 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - AUClast (sitravatinib)
Time frame: Up to 72 hours after dosing
AUC from time zero to the last measured time point
1 secondary outcome
Adverse Events (AEs)
Time frame: Up to 44 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 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
A Study to Evaluate Different Oral Formulations of KT-621
Healthy Participants
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.
Curtis Chin, MD study director
Mirati Therapeutics
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 sitravatinib in people with Healthy Adults, run by Mirati Therapeutics 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 5 inclusion and 7 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 6 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 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?
Pharmacokinetics - Cmax (sitravatinib) (time frame: Up to 72 hours after dosing). 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?
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 6 Apr 2022.