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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Supaglutide injection; Drug: Digoxin; Drug: Metformin

• Registration Number: NCT05694221
• Lead Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-23
• Study Start: 2023-03-20
• Primary Completion: 2023-06-06
• Study Completion: 2023-08-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group A: Digoxin combined with Supaglutide group	Supaglutide injection	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 A: Digoxin combined with Supaglutide group	Digoxin	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 B: Metformin combined with Supaglutide Group	Supaglutide injection	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 B: Metformin combined with Supaglutide Group	Metformin	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.

Primary Outcome Measures

Name	Time	Method
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 B: Plasma AUC0-tau of Metformin	34 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

Secondary Outcome Measures

Name	Time	Method
Group B: Plasma Vz/F of metformin	34 Days	when given in combination with suplaglutide in healthy volunteers
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

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China