Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Rosuvastatin; Drug: Sotorasib

• Registration Number: NCT05045638
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-20
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2021-10-10
• Study Completion: 2021-10-10
• Status Verified: 2022-10
• Results First Submitted: 2022-10-03
• Results First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin alone	Rosuvastatin	-
Rosuvastatin + sotorasib	Rosuvastatin	-
Rosuvastatin + sotorasib	Sotorasib	-

Primary Outcome Measures

Name	Time	Method
AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin	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.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin	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	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 Outcome Measures

Name	Time	Method
Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs)	Day 1 to Day 41	Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms (ECGs), and vital signs results were recorded as AEs.
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	The PK parameters were determined using standard non-compartmental methods.
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	The PK parameters were determined using standard non-compartmental methods.
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	The PK parameters were determined using standard non-compartmental methods.

Trial Locations

Locations (1)

Covance Clinical Research Unit - Daytona Beach; 🇺🇸 Daytona Beach, Florida, United States