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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05550129
Collaborator
(none)
13
Enrollment
1
Location
1
Arm
12
Actual Duration (Days)
33
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase I, Open-label Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Subjects
Actual Study Start Date :
Nov 13, 2019
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Nov 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 510 + Metformin

Drug: AMG 510
Oral tablet

Drug: Metformin
Oral tablet

Outcome Measures

Primary Outcome Measures

  1. Maximum Plasma Concentration (Cmax) of Metformin [Day 1 and Day 8]

  2. Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin [Day 1 and Day 8]

  3. AUC from Time Zero to Infinity (AUCinf) of Metformin [Day 1 and Day 8]

  4. Cmax of AMG 510 [Day 4 and Day 8]

  5. AUClast of AMG 510 [Day 4 and Day 8]

  6. AUCinf of AMG 510 [Day 4 and Day 8]

Secondary Outcome Measures

  1. 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.

  2. Plasma Concentration of AMG 510 Metabolite M24 [Day 4 and Day 8]

  3. Urine Concentration of Metformin [Day 1 and Day 8]

  4. Cmax of Metformin [Day 4 and Day 8]

  5. AUClast of Metformin [Day 4 and Day 8]

  6. AUCinf of Metformin [Day 4 and Day 8]

  7. Rate of Renal Clearance of Metformin [Day 4 and Day 8]

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit Madison Wisconsin United States 53704

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05550129
Other Study ID Numbers:
  • 20190317
First Posted:
Sep 22, 2022
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
Healthy volunteers
AMG 510
Metformin
Additional relevant MeSH terms:
Metformin

Study Results

No Results Posted as of Jan 11, 2023