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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: AMG 510

• Registration Number: NCT05581758
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Primary Completion: 2019-11-25
• Study Completion: 2019-12-09
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence AB	AMG 510	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.
Treatment Sequence BA	AMG 510	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.

Primary Outcome Measures

Name	Time	Method
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
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510	Day 1 and Day 4

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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