A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects

The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AMG 510

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Unit, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male participants or female participants, 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence AB; Participants will be administered AMG 510 orally in the following order: Period 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions.	Drug: AMG 510; Oral Tablet; Other Names: Sotorasib
Experimental: Treatment Sequence BA; Participants will be administered AMG 510 orally in the following order: Period 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions.	Drug: AMG 510; Oral Tablet; Other Names: Sotorasib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510	Day 1 and Day 4
Maximum Plasma Concentration (Cmax) of AMG 510	Day 1 and Day 4
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510	Day 1 and Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with an Adverse Event (AE)	Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.	Day 1 to Day 6
Cmax of AMG 510 Metabolite M24		Day 1 and Day 4
AUClast of AMG 510 Metabolite M24		Day 1 and Day 4
AUCinf of AMG 510 Metabolite M24		Day 1 and Day 4

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Participants; Sotorasib; AMG 510
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Sotorasib
• Other Study ID Numbers: 20190316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No