Clinical trial NCT05694221: Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin
Official title: A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
First posted: 2023-01-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Group A: Plasma Cmax of digoxin
timeFrame: 39 Days
measure: Group A: Plasma AUC0-last of digoxin
timeFrame: 39 Days
measure: Group A: Plasma AUC0-inf of digoxin
timeFrame: 39 Days
measure: Group B: Plasma Cmax,ss of Metformin
timeFrame: 34 Days
measure: Group B: Plasma AUC0-tau of Metformin
timeFrame: 34 Days
Secondary outcomes:
measure: Group A: Plasma Tmax of Digoxin
timeFrame: 39 Days
measure: Group A: Plasma t1/2 of digoxin
timeFrame: 39 Days
measure: Group A: Plasma CL/F of digoxin
timeFrame: 39 Days
measure: Group A: Plasma Vz/F of digoxin
timeFrame: 39 Days
measure: Group B: Plasma Tmax of Metformin
timeFrame: 34 Days
measure: Group B: Plasma Cmin,ss of Metformin
timeFrame: 34 Days
measure: Group B: Plasma t1/2 of Metformin
timeFrame: 34 Days
measure: Group B: Plasma CL/F of Metformin
timeFrame: 34 Days
measure: Group B: Plasma Vz/F of metformin
timeFrame: 34 Days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References: