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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550129
• Other study ID #: 20190317
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: January 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AMG 510
Oral tablet
• Metformin
Oral tablet

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of Metformin		Day 1 and Day 8
Primary	Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin		Day 1 and Day 8
Primary	AUC from Time Zero to Infinity (AUCinf) of Metformin		Day 1 and Day 8
Primary	Cmax of AMG 510		Day 4 and Day 8
Primary	AUClast of AMG 510		Day 4 and Day 8
Primary	AUCinf of AMG 510		Day 4 and Day 8
Secondary	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
Secondary	Plasma Concentration of AMG 510 Metabolite M24		Day 4 and Day 8
Secondary	Urine Concentration of Metformin		Day 1 and Day 8
Secondary	Cmax of Metformin		Day 4 and Day 8
Secondary	AUClast of Metformin		Day 4 and Day 8
Secondary	AUCinf of Metformin		Day 4 and Day 8
Secondary	Rate of Renal Clearance of Metformin		Day 4 and Day 8
Secondary	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

External Links

•   AmgenTrials clinical trials website