Phase 1
Completed N=145
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT05048784 ↗
Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B — 6650; 6540 ng/mL
Summary
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B |
6650; 6540 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B |
27800; 27500 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B |
28600; 27700 | — |
| SECONDARY Number of Participants Who Experienced a Treatment-emergent AE (TEAE) |
8; 10; 0 | — |
| SECONDARY Food Effect: Cmax of Sotorasib |
6390; 6790; 6400 | — |
| SECONDARY Food Effect: AUClast of Sotorasib |
23900; 26100; 34500 | — |
| SECONDARY Food Effect: AUCinf of Sotorasib |
23500; 26500; 34700 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 (NCT05048784). 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.