Phase 1
Completed N=16
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT05497557 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Sotorasib — 7160; 4850 ng/mL
Summary
The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Sotorasib |
7160; 4850 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib |
30200; 23500 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib |
30000; 23200 | — |
| SECONDARY Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) |
0; 2; 0 | — |
Eligibility Criteria
Inclusion:
- Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.
- Females of nonchildbearing potential.
Exclusion:
- Inability to swallow oral medication or history of malabsorption syndrome.
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- Poor peripheral venous access.
- History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
Data sourced from ClinicalTrials.gov (NCT05497557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.