Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Sotorasib

• Registration Number: NCT04887064
• Lead Sponsor: Amgen

Brief Summary

The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-22
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-14
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Status Verified: 2023-01
• Results First Submitted: 2023-01-23
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	Sotorasib	-
Normal Hepatic Function	Sotorasib	-
Severe Hepatic Impairment	Sotorasib	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Maximum Observed Plasma Concentration (Cmax) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

Secondary Outcome Measures

Name	Time	Method
Unbound AUCinf (AUCinf,u) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Unbound AUClast (AUClast,u) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Unbound Apparent Volume of Distribution During the Terminal Phase (Vz,u/F) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Unbound Apparent Total Plasma Clearance (CLu/F) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1
Number of Participants Who Experienced One or More Treatment Emergent Adverse Events (TEAEs)	Day 1 to Day 8	TEAEs were defined as any adverse events (AEs) that started during or after dosing, or started prior to dosing and increased in severity after dosing.; Any clinically significant changes in clinical laboratory evaluations, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Unbound Cmax (Cmax,u) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

Trial Locations

Locations (5)

Pinnacle Clinical Research - San Antonio; 🇺🇸 San Antonio, Texas, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

American Research Corporation; 🇺🇸 San Antonio, Texas, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Clinical Pharmacology Of Miami LLC; 🇺🇸 Miami, Florida, United States