Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin

NCT ID: NCT05694221

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2023-08-17

Brief Summary

This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.

Detailed Description

This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group A: Digoxin combined with Supaglutide group

Subjects 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 Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered subcutaneously in the Supaglutide arms

Digoxin

Intervention Type: DRUG

Oral Administration

Group B: Metformin combined with Supaglutide Group

Subjects 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.

Group Type: EXPERIMENTAL

Supaglutide injection

Intervention Type: DRUG

Administered subcutaneously in the Supaglutide arms

Metformin

Intervention Type: DRUG

Oral Administration

Interventions

Supaglutide injection

Administered subcutaneously in the Supaglutide arms

Intervention Type: DRUG

Digoxin

Oral Administration

Intervention Type: DRUG

Metformin

Oral Administration

Intervention Type: DRUG

Other Intervention Names

Diabegone; Digoxin Tablets; Glucophage

Eligibility Criteria

Inclusion Criteria

1. Healthy Chinese subjects.

2. Age between 18 and 45 years, inclusive.

3. 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.

4. Subjects with no plan of pragnancy within the screening period up to 3 months after the last dose and who are voluntarily using contraception.

6. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

1. Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.

2. 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.

3. 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

4. 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

5. those with existing symptoms of unexplained infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Zhang

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40587051 (View on PubMed)

Other Identifiers

YN011-D01

Identifier Type: -

Identifier Source: org_study_id