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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rosuvastatin alone
Intervention: Rosuvastatin (Drug)
Rosuvastatin + sotorasib
Intervention: Rosuvastatin (Drug)
Rosuvastatin + sotorasib
Intervention: Sotorasib (Drug)
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin
Time Frame: 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
The PK parameters were determined using standard non-compartmental methods.
AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin
Time Frame: 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
The PK parameters were determined using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin
Time Frame: 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
The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods.
Secondary Outcomes
- Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs)(Day 1 to Day 41)
- AUCinf of Sotorasib(Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6)
- Cmax of Sotorasib(Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6)
- AUClast of Sotorasib(Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6)