Last updated: 10/01/2026 05:51:02
A study to investigate the effect of omeprazole and cyclosporine on velzatinib in healthy participants
GSK study ID
301002
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Maximum observed plasma concentration (Cmax)
Timeframe: Up to 72 hours
Area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72 hours])
Timeframe: Up to 72 hours
Secondary outcomes:
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Timeframe: Up to 47 days
Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs
Timeframe: Up to 47 days
Time to maximum observed plasma drug concentration (Tmax)
Timeframe: Up to 72 hours
Interventions:
Drug: Velzatinib
Drug: Cyclosporine
Drug: Omeprazole
Enrollment:
36
Primary completion date:
2027-12-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy participants, Gastrointestinal Neoplasms
Product
GSK6042981
Collaborators
Not applicable
Study date(s)
October 2026 to January 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 Years
Accepts healthy volunteers
Yes
- 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 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
Is 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
Exclusion criteria:
- 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.
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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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