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

Phase 1

Completed

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

• Registration Number: NCT05598281
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Primary Completion: 2019-11-19
• Study Completion: 2019-11-19
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 510 + Digoxin	Digoxin	Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.
AMG 510 + Digoxin	AMG 510	Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.

Primary Outcome Measures

Name	Time	Method
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
AUCinf of Digoxin Administered in Combination with AMG 510	Day 7
Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone	Day 1

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

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