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

Sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694221

Collaborator

Huashan Hospital (Other)

Enrollment

Arms

10.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Supaglutide injection Drug: Digoxin Drug: Metformin	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Supaglutide injection Administered subcutaneously in the Supaglutide arms Other Names: Diabegone Drug: Digoxin Digoxin
Experimental: 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.	Drug: Supaglutide injection Administered subcutaneously in the Supaglutide arms Other Names: Diabegone Drug: Metformin Metformin

Arm

Intervention/Treatment

Experimental: 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.

Drug: Supaglutide injection

Administered subcutaneously in the Supaglutide arms

Other Names:

Diabegone

Drug: Digoxin

Digoxin

Experimental: 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.

Drug: Supaglutide injection

Administered subcutaneously in the Supaglutide arms

Other Names:

Diabegone

Drug: Metformin

Metformin

Outcome Measures

Primary Outcome Measures

Group A: Plasma Cmax of digoxin [39 Days]
when given in combination with supaglutide in healthy volunteers
Group A: Plasma AUC0-last of digoxin [39 Days]
when given in combination with suplaglutide in healthy volunteers
Group A: Plasma AUC0-inf of digoxin [39 Days]
when given in combination with supaglutide in healthy volunteers
Group B: Plasma Cmax,ss of Metformin [34 Days]
when given in combination with supaglutide in healthy volunteers
Group B: Plasma AUC0-tau of Metformin [34 Days]
when given in combination with suplaglutide in healthy volunteers

Secondary Outcome Measures

Group A: Plasma Tmax of Digoxin [39 Days]
when given in combination with supaglutide in healthy volunteers
Group A: Plasma t1/2 of digoxin [39 Days]
when given in combination with supaglutide in healthy volunteers
Group A: Plasma CL/F of digoxin [39 Days]
when given in combination with suplaglutide in healthy volunteers
Group A: Plasma Vz/F of digoxin [39 Days]
when given in combination with supaglutide in healthy volunteers
Group B: Plasma Tmax of Metformin [34 Days]
when given in combination with supaglutide in healthy volunteers
Group B: Plasma Cmin,ss of Metformin [34 Days]
when given in combination with suplaglutide in healthy volunteers
Group B: Plasma t1/2 of Metformin [34 Days]
when given in combination with suplaglutide in healthy volunteers
Group B: Plasma CL/F of Metformin [34 Days]
when given in combination with suplaglutide in healthy volunteers
Group B: Plasma Vz/F of metformin [34 Days]
when given in combination with suplaglutide in healthy volunteers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Huashan Hospital

Investigators

Principal Investigator: Jing Zhang, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05694221

Other Study ID Numbers:

YN011-D01

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metformin

Digoxin

Study Results

No Results Posted as of Jan 23, 2023