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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
AMG 510 + Digoxin
Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.
Intervention: AMG 510 (Drug)
AMG 510 + Digoxin
Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.
Intervention: Digoxin (Drug)
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone
Time Frame: Day 1
AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone
Time Frame: Day 1
Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510
Time Frame: Day 7
AUClast of Digoxin Administered in Combination with AMG 510
Time Frame: Day 7
AUCinf of Digoxin Administered in Combination with AMG 510
Time Frame: Day 7
Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone
Time Frame: Day 1
Secondary Outcomes
- Number of Participants with an Adverse Event (AE)(Day 1 to Day 13)
- 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)