Back to Search Results
Study Complete
Sponsor ID
20190315

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

Sponsor ID
20190315
Clinicaltrials.gov ID
NCT05598281
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
14
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone

Timeframe: Day 1

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone

Timeframe: Day 1

AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone

Timeframe: Day 1

Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510

Timeframe: Day 7

AUClast of Digoxin Administered in Combination with AMG 510

Timeframe: Day 7

AUCinf of Digoxin Administered in Combination with AMG 510

Timeframe: Day 7

Secondary Outcome Measures

Number of Participants with an Adverse Event (AE)

Timeframe: Day 1 to Day 13

Cmax of AMG 510 Administered in Combination with Digoxin

Timeframe: Day 7

AUClast of AMG 510 Administered in Combination with Digoxin

Timeframe: Day 7

AUCinf of AMG 510 Administered in Combination with Digoxin

Timeframe: Day 7

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit, Inc
Daytona Beach, FL, United States, 32117
Status
Completed
Study Info
Age
18 - 60 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Nov 2019 - Nov 2019
    Inclusion and Exclusion Criteria
    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.