Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Participants

Study Overview
=================
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.

Official Title
-----------------
A Phase I, Open-label Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AMG 510
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening. Body mass index, between 18 and 30 kg/m^2 (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 participant safety or interfere with the study evaluation, procedures, or completion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 510 + Metformin<br> | Drug: AMG 510<br>* Oral tablet<br>Drug: Metformin<br>* Oral tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 10 | 
| 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 | 
| Rate of Renal Clearance of Metformin |  | Day 4 and Day 8 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers, AMG 510, Metformin