A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy Participants

NCT07862114 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 301002
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants; Gastrointestinal Neoplasms

Keywords

Breast cancer resistance protein; Cyclosporine; Omeprazole; Healthy participants; P-glycoprotein; Proton Pump Inhibitor; Velzatinib

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax)

  Up to 72 hours

• Area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72 hours])

  Up to 72 hours

Secondary Outcomes (3)

• Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity

  Up to 47 days

• Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs

  Up to 47 days

• Time to maximum observed plasma drug concentration (Tmax)

  Up to 72 hours

Study Arms (3)

Participants receiving velzatinib

EXPERIMENTAL

Drug: Velzatinib

Participants receiving omeprazole + velzatinib

EXPERIMENTAL

Drug: Velzatinib; Drug: Omeprazole

Participants receiving velzatinib + cyclosporine

EXPERIMENTAL

Drug: Velzatinib; Drug: Cyclosporine

Interventions

Velzatinib DRUG

Velzatinib will be administered.

Also known as: GSK6042981/IDRX-42

Participants receiving omeprazole + velzatinib; Participants receiving velzatinib; Participants receiving velzatinib + cyclosporine

Cyclosporine DRUG

Cyclosporine will be administered.

Participants receiving velzatinib + cyclosporine

Omeprazole DRUG

Omeprazole will be administered.

Participants receiving omeprazole + velzatinib

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Cyclosporine; Omeprazole

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 7, 2026
• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.