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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Metformin; Drug: Digoxin; Drug: Supaglutide injection

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Zhang; Phone Number: 13761724886; Email: yan.zhang@innogenpharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Digoxin; Digoxin; Drug: Supaglutide injection; Administered subcutaneously in the Supaglutide arms; Other Names: Diabegone
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: Metformin; Metformin; Drug: Supaglutide injection; Administered subcutaneously in the Supaglutide arms; Other Names: Diabegone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
• Collaborators: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin; Metformin
• Other Study ID Numbers: YN011-D01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No