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Targeted Therapy

Omeprazole + Sotorasib for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose (hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on days 1 and 9
Awards & highlights

Summary

This trial is testing how a stomach acid-reducing medication and an acidic drink affect the way a drug is processed in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose (hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on days 1 and 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose (hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on days 1 and 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Secondary outcome measures
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Omeprazole + SotorasibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omeprazole
2006
Completed Phase 4
~940
Sotorasib
2021
Completed Phase 1
~370

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,381,104 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,251 Total Patients Enrolled
~5 spots leftby Sep 2025
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