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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05598281
• Other study ID #: 20190315
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2019
• Est. completion date: November 19, 2019

Study information

• Verified date: September 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AMG 510
Oral tablet
• Digoxin
Oral tablet

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone		Day 1
Primary	Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone		Day 1
Primary	AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone		Day 1
Primary	Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510		Day 7
Primary	AUClast of Digoxin Administered in Combination with AMG 510		Day 7
Primary	AUCinf of Digoxin Administered in Combination with AMG 510		Day 7
Secondary	Number of Participants with an Adverse Event (AE)	Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.	Day 1 to Day 13
Secondary	Cmax of AMG 510 Administered in Combination with Digoxin		Day 7
Secondary	AUClast of AMG 510 Administered in Combination with Digoxin		Day 7
Secondary	AUCinf of AMG 510 Administered in Combination with Digoxin		Day 7

External Links

•   AmgenTrials clinical trials website