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

NCT04887064 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20200362
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment; Sotorasib

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (6)

• Number of Participants Who Experienced One or More Treatment Emergent Adverse Events (TEAEs)

  Day 1 to Day 8

• 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

• 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 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 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

Study Arms (3)

Normal Hepatic Function

EXPERIMENTAL

Drug: Sotorasib

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: Sotorasib

Severe Hepatic Impairment

EXPERIMENTAL

Drug: Sotorasib

Interventions

Sotorasib DRUG

Sotorasib will be administered as an oral tablet.

Also known as: AMG 510

Moderate Hepatic Impairment; Normal Hepatic Function; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants
• Participant has provided informed consent before initiation of any study-specific activities/procedures
• Participants between 18 and 70 years of age
• Body mass index between 18 and 38 kg/m\^2
• Females of nonchildbearing potential defined as permanently sterile or postmenopausal
• Participants with Normal Hepatic Function
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
• Participants with Hepatic Impairment
• Child-Pugh B or C classification with clinical laboratory values and clinical examination findings
• Documented medical history of chronic liver disease

You may not qualify if:

• All Participants
• Female participants with a positive pregnancy test at Screening or Check-in
• Male participants with a pregnant partner or partner planning to become pregnant who are unwilling to practice abstinence or use a condom for 7 days after dosing
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• Participant has received a dose of an investigational drug (new chemical entity) within the past 30 days or 5 half-lives, whichever is longer, prior to Check-in
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer)
• All herbal medicines vitamins, and supplements consumed by the subject within the 30 days prior to enrollment
• Alcohol consumption from 48 hours prior to Check-in
• Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Check-in
• Positive human immunodeficiency virus test at Screening
• Participants with Normal Hepatic Function
• Positive hepatitis B or hepatitis C panel at Screening. Subjects whose results are compatible with prior immunity (vaccination or prior infection) may be included
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN) at Screening or Check-in
• Total bilirubin levels \> ULN at Screening or Check-in
• A QT interval corrected for heart rate based on the Fridericia correction (QTcF) interval \> 450 msec in male subjects or \> 470 msec in female subjects or history/evidence of long QT syndrome at Screening or Check-in, confirmed by calculating the mean of the original value and 2 repeats

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Pharmacology Of Miami LLC

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

sotorasib

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: April 22, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (5)