A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants

NCT05571163 | Completed Phase 1 FDA Drug

• 1 other identifier: 20190500
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.

Conditions

Healthy Participants

Keywords

Healthy participants; AMG 510

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of AMG 510

  Day 1 and Day 4

• Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510

  Day 1 and Day 4

• Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510

  Day 1 and Day 4

Secondary Outcomes (1)

• Number of Participants with an Adverse Event (AE)

  Day 1 to Day 6

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

Participants will be administered AMG 510 in the following order: Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water.

Drug: AMG 510

Treatment Sequence BA

EXPERIMENTAL

Participants will be administered AMG 510 in the following order: Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets.

Drug: AMG 510

Interventions

AMG 510 DRUG

Tablets

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects or healthy female between 18 and 55 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

You may not qualify if:

• 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.
• Inability to swallow oral medication or history of malabsorption syndrome.
• Poor peripheral venous access.
• History of significant 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E

Dallas, Texas, 75247, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

sotorasib

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: March 6, 2020
• Primary Completion: June 14, 2020
• Study Completion: June 14, 2020
• Last Updated: October 7, 2022

Record last verified: 2022-09

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 (1)