Back to Search Results
Study Complete
Sponsor ID
20190500

A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants

Sponsor ID
20190500
Clinicaltrials.gov ID
NCT05571163
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
13
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of AMG 510

Timeframe: Day 1 and Day 4

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510

Timeframe: Day 1 and Day 4

Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510

Timeframe: Day 1 and Day 4

Secondary Outcome Measures

Number of Participants with an Adverse Event (AE)

Timeframe: Day 1 to Day 6

Study Documents

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

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E
Dallas, Texas, United States, 75247
Status
Completed
Study Info
Age
18 - 55 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Mar 2020 - Jun 2020
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Healthy male subjects or healthy female between 18 and 55 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:
    -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. -Inability to swallow oral medication or history of malabsorption syndrome. -Poor peripheral venous access. -History of significant 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.