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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05694221
• Other study ID #: YN011-D01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
• Contact: Yan Zhang
• Phone: 13761724886
• Email: yan.zhang[@]innogenpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Supaglutide injection
Administered subcutaneously in the Supaglutide arms
• Digoxin
Digoxin
• Metformin
Metformin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.	Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group A: Plasma Cmax of digoxin	when given in combination with supaglutide in healthy volunteers	39 Days
Primary	Group A: Plasma AUC0-last of digoxin	when given in combination with suplaglutide in healthy volunteers	39 Days
Primary	Group A: Plasma AUC0-inf of digoxin	when given in combination with supaglutide in healthy volunteers	39 Days
Primary	Group B: Plasma Cmax,ss of Metformin	when given in combination with supaglutide in healthy volunteers	34 Days
Primary	Group B: Plasma AUC0-tau of Metformin	when given in combination with suplaglutide in healthy volunteers	34 Days
Secondary	Group A: Plasma Tmax of Digoxin	when given in combination with supaglutide in healthy volunteers	39 Days
Secondary	Group A: Plasma t1/2 of digoxin	when given in combination with supaglutide in healthy volunteers	39 Days
Secondary	Group A: Plasma CL/F of digoxin	when given in combination with suplaglutide in healthy volunteers	39 Days
Secondary	Group A: Plasma Vz/F of digoxin	when given in combination with supaglutide in healthy volunteers	39 Days
Secondary	Group B: Plasma Tmax of Metformin	when given in combination with supaglutide in healthy volunteers	34 Days
Secondary	Group B: Plasma Cmin,ss of Metformin	when given in combination with suplaglutide in healthy volunteers	34 Days
Secondary	Group B: Plasma t1/2 of Metformin	when given in combination with suplaglutide in healthy volunteers	34 Days
Secondary	Group B: Plasma CL/F of Metformin	when given in combination with suplaglutide in healthy volunteers	34 Days
Secondary	Group B: Plasma Vz/F of metformin	when given in combination with suplaglutide in healthy volunteers	34 Days