Healthy Volunteers
Conditions
Keywords
Healthy volunteers, AMG 510, Metformin
Brief summary
The primary objectives of this study are to evaluate the effect of AMG 510 on the pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of metformin on the PK of AMG 510 in healthy participants.
Interventions
DRUGAMG 510
Oral tablet
DRUGMetformin
Oral tablet
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening. 2. Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening. 3. Females of nonchildbearing potential.
Exclusion criteria
1. Inability to swallow oral medication or history of malabsorption syndrome. 2. 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. 3. Poor peripheral venous access. 4. 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 participant safety or interfere with the study evaluation, procedures, or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of Metformin | Day 1 and Day 8 |
| Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin | Day 1 and Day 8 |
| AUC from Time Zero to Infinity (AUCinf) of Metformin | Day 1 and Day 8 |
| Cmax of AMG 510 | Day 4 and Day 8 |
| AUClast of AMG 510 | Day 4 and Day 8 |
| AUCinf of AMG 510 | Day 4 and Day 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Renal Clearance of Metformin | Day 4 and Day 8 | — |
| Number of Participants with an Adverse Event (AE) | Day 1 to Day 10 | Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs. |
| Area Under the Glucose Concentration-time Curve from Time 0 to 2 Hours After Glucose Administration (AUC0-2) | Day 1, Day 4 and Day 8 | — |
| Plasma Concentration of AMG 510 Metabolite M24 | Day 4 and Day 8 | — |
| Urine Concentration of Metformin | Day 1 and Day 8 | — |
| Cmax of Metformin | Day 4 and Day 8 | — |
| AUClast of Metformin | Day 4 and Day 8 | — |
| AUCinf of Metformin | Day 4 and Day 8 | — |
Countries
United States
Outcome results
None listed