Phase 1
Completed N=13
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT05045638 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin — 3.80; 6.47 ng/mL
Summary
A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin |
3.80; 6.47 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin |
33.20; 44.50 | — |
| PRIMARY AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin |
36.20; 48.40 | — |
| SECONDARY Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs) |
0; 0 | — |
| SECONDARY Cmax of Sotorasib |
4650 | — |
| SECONDARY AUClast of Sotorasib |
22500 | — |
| SECONDARY AUCinf of Sotorasib |
22900 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m2 (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 subject safety or interfere with the study evaluation, procedures, or completion.
Data sourced from ClinicalTrials.gov (NCT05045638). 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.