Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin
A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics
1 other identifier
interventional
34
1 country
1
Brief Summary
This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedStudy Start
First participant enrolled
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2023
CompletedAugust 5, 2024
August 1, 2024
3 months
January 12, 2023
August 1, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Group A: Plasma Cmax of digoxin
when given in combination with supaglutide in healthy volunteers
39 Days
Group A: Plasma AUC0-last of digoxin
when given in combination with suplaglutide in healthy volunteers
39 Days
Group A: Plasma AUC0-inf of digoxin
when given in combination with supaglutide in healthy volunteers
39 Days
Group B: Plasma Cmax,ss of Metformin
when given in combination with supaglutide in healthy volunteers
34 Days
Group B: Plasma AUC0-tau of Metformin
when given in combination with suplaglutide in healthy volunteers
34 Days
Secondary Outcomes (9)
Group A: Plasma Tmax of Digoxin
39 Days
Group A: Plasma t1/2 of digoxin
39 Days
Group A: Plasma CL/F of digoxin
39 Days
Group A: Plasma Vz/F of digoxin
39 Days
Group B: Plasma Tmax of Metformin
34 Days
- +4 more secondary outcomes
Study Arms (2)
Group A: Digoxin combined with Supaglutide group
EXPERIMENTALSubjects will receive a single oral dose of 0.25 mg digoxin tablets on Day 1. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）. Then receive another single oral dose of 0.25 mg digoxin tablets on Day 35.
Group B: Metformin combined with Supaglutide Group
EXPERIMENTALSubjects will receive multiple oral dose of Metformin tablets on Day 1-3. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）. Then receive another round of Metformin tablets on Day 32-34.
Interventions
Administered subcutaneously in the Supaglutide arms
Oral Administration
Oral Administration
Eligibility Criteria
You may qualify if:
- Healthy Chinese subjects.
- Age between 18 and 45 years, inclusive.
- Body mass index \[BMI = weight (kg)/height2 (m2)\] of between 20 and 28 kg/m2 (including thresholds), with male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg.
- Subjects with no plan of pragnancy within the screening period up to 3 months after the last dose and who are voluntarily using contraception.
- \. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
You may not qualify if:
- Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.
- Subjects with a previous or existing disease affecting the absorption, distribution, metabolism or excretion of drugs, such as active peptic ulcers or bleeding, history of ulcers or bleeding, acute and chronic pancreatitis, etc.
- Subjects with a history or family history of C-cell tumours/carcinoma of the thyroid gland, or a previous history of thyroid insufficiency or thyroid hormone abnormalities
- Subjects who have undergone major surgery within 4 weeks prior to screening which, in the judgment of the investigator, may affect this trial, such as gastric and duodenal surgery, cholecystectomy, nephrectomy, or removal of malignant tumours (except for previous appendectomy), or those who are scheduled to undergo major surgery during the trial
- those with existing symptoms of unexplained infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Related Publications (1)
Wu X, He J, Wu J, Liu W, Xu Y, Li Y, Zhang J, Wang Q. Effect of Efsubaglutide Alfa on the Pharmacokinetics of Metformin and Digoxin in Healthy Participants. Clin Pharmacokinet. 2025 Sep;64(9):1367-1377. doi: 10.1007/s40262-025-01541-0. Epub 2025 Jun 30.
PMID: 40587051DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Zhang
Huashan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 23, 2023
Study Start
March 20, 2023
Primary Completion
June 6, 2023
Study Completion
August 17, 2023
Last Updated
August 5, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share