A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

An Open-label Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics of AMG 510 in Healthy Subjects Under Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05599828

Enrollment

Registered

2022-10-31

Start date

2020-07-17

Completion date

2020-09-13

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy Participants, AMG 510, Famotidine, Omeprazole

Brief summary

The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.

Interventions

DRUGOmeprazole

Capsule

DRUGFamotidine

Tablet

DRUGAMG 510

Oral Tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects or female subjects, 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.

Design outcomes

Primary

Measure	Time frame
Maximum Observed Plasma Concentration (Cmax) of AMG 510	Day 1, Day 4, Day 11
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510	Day 1, Day 4, Day 11
AUC from time Zero to Infinity (AUCinf) of AMG 510	Day 1, Day 4, Day 11

Secondary

Measure	Time frame	Description
Number of Participants with an Adverse Event (AE)	Day 1 to Day 13	Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026