Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants

An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05598281

Enrollment

Registered

2022-10-28

Start date

2019-11-05

Completion date

2019-11-19

Last updated

2025-04-02

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

Conditions

Healthy Participants

Keywords

AMG 510, Healthy Participants, Digoxin

Brief summary

The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.

Interventions

DRUGAMG 510

Oral tablet

DRUGDigoxin

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
AUCinf of Digoxin Administered in Combination with AMG 510	Day 7
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone	Day 1
AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone	Day 1
Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510	Day 7
AUClast of Digoxin Administered in Combination with AMG 510	Day 7
Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone	Day 1

Secondary

Measure	Time frame	Description
Cmax of AMG 510 Administered in Combination with Digoxin	Day 7	—
AUClast of AMG 510 Administered in Combination with Digoxin	Day 7	—
AUCinf of AMG 510 Administered in Combination with Digoxin	Day 7	—
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