Clinical trial · Interventional
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
A Phase I, Open-label, Fixed Sequence Crossover Study to Investigate the Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin, a Breast Cancer Resistance Protein Substrate, in Healthy Subjects
NCT05045638CI-TRIAL-00068729completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Participants | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rosuvastatin | Drug | — | UNRESOLVED |
| Sotorasib | Drug | Sotorasib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rosuvastatin alone
- interventionNames
- Drug: Rosuvastatin
- type
- EXPERIMENTAL
- label
- Rosuvastatin + sotorasib
- interventionNames
- Drug: Rosuvastatin
- Drug: Sotorasib
Primary outcomes (3)
- measure
- Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin
- timeFrame
- Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
- description
- The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.