Healthy ParticipantsPhase 1NCT07862114
A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy Participants
A Phase 1 study testing Velzatinib, Cyclosporine and Omeprazole in people with Healthy Participants and Gastrointestinal Neoplasms, run by GlaxoSmithKline.
Trial summary
This study will look at how two commonly used medicines, omeprazole and cyclosporine, influence the way the body absorbs, processes, and eliminates velzatinib in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Gastrointestinal Neoplasms
- What is being tested?
- Velzatinib, Cyclosporine and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2026to 12 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- Healthy as determined by investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital sign measurements, and cardiac monitoring.
- Has a body mass index (BMI) from 18.0 to less than (<) 30.0 kilograms per square meter (kg/m^2).
Who cannot join
- Has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.
- Presence (within 6 months) or history of significant liver or gastrointestinal (GI) disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption [e.g., bariatric surgery or bowel resection], or clinically significant esophageal reflux), or surgery that may affect bioavailability as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Non-Randomized, Open-Label, Parallel-Group Study to Investigate the Effects of Coadministration of the Proton Pump Inhibitor Omeprazole or the P-gp/BCRP Inhibitor Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Healthy Participants
This study will look at how two commonly used medicines, omeprazole and cyclosporine, influence the way the body absorbs, processes, and eliminates velzatinib in healthy volunteers.
- Conditions
- Healthy Participants, Gastrointestinal Neoplasms
- Being tested
- Velzatinib, Cyclosporine, Omeprazole
- Keywords
- Breast cancer resistance protein, Cyclosporine, Omeprazole, Healthy participants, P-glycoprotein, Proton Pump Inhibitor, Velzatinib
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelzatinibDrug
Also called GSK6042981/IDRX-42
Velzatinib will be administered.
CyclosporineDrug
Cyclosporine will be administered.
OmeprazoleDrug
Omeprazole will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving velzatinib | Experimental | Not described Receives: Drug: Velzatinib |
| Participants receiving omeprazole + velzatinib | Experimental | Not described Receives: Drug: Velzatinib; Drug: Omeprazole |
| Participants receiving velzatinib + cyclosporine | Experimental | Not described Receives: Drug: Velzatinib; Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 72 hours
Area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72 hours])
Measured: Up to 72 hours
Secondary outcomes (3)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Measured: Up to 47 days
Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs
Measured: Up to 47 days
Time to maximum observed plasma drug concentration (Tmax)
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
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
- NCT07862114
- Sponsor's protocol ID
- 301002
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Non-Randomized, Open-Label, Parallel-Group Study to Investigate the Effects of Coadministration of the Proton Pump Inhibitor Omeprazole or the P-gp/BCRP Inhibitor Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Healthy Participants
- ClinicalTrials.gov ID
- NCT07862114
- Acronym / sponsor ID
- 301002
- Conditions
- Healthy Participants, Gastrointestinal Neoplasms
- Keywords
- Breast cancer resistance protein, Cyclosporine, Omeprazole, Healthy participants, P-glycoprotein, Proton Pump Inhibitor, Velzatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This study will look at how two commonly used medicines, omeprazole and cyclosporine, influence the way the body absorbs, processes, and eliminates velzatinib in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants receiving velzatinib | Experimental | Drug: Velzatinib |
| Participants receiving omeprazole + velzatinib | Experimental | Drug: Velzatinib, Drug: Omeprazole |
| Participants receiving velzatinib + cyclosporine | Experimental | Drug: Velzatinib, Drug: Cyclosporine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- Healthy as determined by investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital sign measurements, and cardiac monitoring.
- Has a body mass index (BMI) from 18.0 to less than (<) 30.0 kilograms per square meter (kg/m^2).
Key exclusion criteria (2 listed)
- Has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.
- Presence (within 6 months) or history of significant liver or gastrointestinal (GI) disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption [e.g., bariatric surgery or bowel resection], or clinically significant esophageal reflux), or surgery that may affect bioavailability as judged by the investigator.
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 |
|---|---|---|
| VelzatinibAlso: GSK6042981/IDRX-42Velzatinib will be administered. | Drug | Participants receiving omeprazole + velzatinib, Participants receiving velzatinib, Participants receiving velzatinib + cyclosporine |
| CyclosporineCyclosporine will be administered. | Drug | Participants receiving velzatinib + cyclosporine |
| OmeprazoleOmeprazole will be administered. | Drug | Participants receiving omeprazole + velzatinib |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 72 hours
Area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72 hours])
Time frame: Up to 72 hours
3 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Time frame: Up to 47 days
Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs
Time frame: Up to 47 days
Time to maximum observed plasma drug concentration (Tmax)
Time frame: Up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Velzatinib, Cyclosporine and Omeprazole in people with Healthy Participants and Gastrointestinal Neoplasms, run by GlaxoSmithKline.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to 72 hours). 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 7 Oct 2026.