Clinical trial NCT05550129: Study to Evaluate the Drug-drug Interactions Between Metformin and 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
AMG 510
Metformin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Metformin
timeFrame: Day 1 and Day 8
measure: Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin
timeFrame: Day 1 and Day 8
measure: AUC from Time Zero to Infinity (AUCinf) of Metformin
timeFrame: Day 1 and Day 8
measure: Cmax of AMG 510
timeFrame: Day 4 and Day 8
measure: AUClast of AMG 510
timeFrame: Day 4 and Day 8
measure: AUCinf of AMG 510
timeFrame: Day 4 and Day 8
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 10
measure: Plasma Concentration of AMG 510 Metabolite M24
timeFrame: Day 4 and Day 8
measure: Urine Concentration of Metformin
timeFrame: Day 1 and Day 8
measure: Cmax of Metformin
timeFrame: Day 4 and Day 8
measure: AUClast of Metformin
timeFrame: Day 4 and Day 8
measure: AUCinf of Metformin
timeFrame: Day 4 and Day 8
measure: Rate of Renal Clearance of Metformin
timeFrame: Day 4 and Day 8
measure: Area Under the Glucose Concentration-time Curve from Time 0 to 2 Hours After Glucose Administration (AUC0-2)
timeFrame: Day 1, Day 4 and Day 8
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: