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

Shanghai Yinnuo Pharmaceutical Technology

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Metformin; Drug: Digoxin; Drug: Supaglutide injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05694221

YN011-D01

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group A: Digoxin combined with Supaglutide group

Experimental group

Description:

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.

Treatment:

Drug: Digoxin

Drug: Supaglutide injection

Group B: Metformin combined with Supaglutide Group

Experimental group

Description:

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.

Treatment:

Drug: Supaglutide injection

Drug: Metformin