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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AMG 510; Drug: Metformin

• Registration Number: NCT05550129
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 510 + Metformin	AMG 510	-
AMG 510 + Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
AUCinf of Metformin	Day 4 and Day 8
AUClast 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

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States