Health TrialsbyHealthPanel

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

ConditionsHealthy ParticipantsGastrointestinal Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Velzatinib

    Drug

    Velzatinib will be administered.

  • Cyclosporine

    Drug

    Cyclosporine will be administered.

  • Omeprazole

    Drug

    Omeprazole will be administered.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Participants receiving velzatinibExperimental treatment 1 intervention
Group B: Participants receiving omeprazole + velzatinibExperimental treatment 2 interventions
Group C: Participants receiving velzatinib + cyclosporineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum observed plasma concentration (Cmax)

Time frame
Up to 72 hours
2

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

Secondary outcomes

1

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

Time frame
Up to 47 days
2

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

Time frame
Up to 47 days
3

Time to maximum observed plasma drug concentration (Tmax)

Time frame
Up to 72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: