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
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