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

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Digoxin; Drug: AMG 510

Study type: Interventional

Funder types: Industry

Identifiers

NCT05598281

20190315

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

AMG 510 + Digoxin

Experimental group

Description:

Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.

Treatment:

Drug: Digoxin

Drug: AMG 510