Assessment of Gastric Emptying by SHR20004 in Healthy Subjects

NCT06137469 | Completed Phase 1

• 1 other identifier: SHR20004-106
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.：(AUC0-300min)

  Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

Secondary Outcomes (14)

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.： (AUC0-60min)

  Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.： (AUC0-60min/AUC0-300min)

  Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.： (Cmax)

  Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.： (Tmax)

  Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

• Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.： (t1/2)

  Based on pre-dose to min post-dose sampling times on Day 1 and Day 31

Study Arms (2)

Acetaminophen+SHR20004

EXPERIMENTAL

Drug: Acetaminophen/SHR20004

Acetaminophen+Placebo

EXPERIMENTAL

Drug: Acetaminophen/Placebo

Interventions

Acetaminophen/SHR20004 DRUG

SHR20004 was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.

Acetaminophen+SHR20004

Acetaminophen/Placebo DRUG

Placebo was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.

Acetaminophen+Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily sign an informed consent form before participating in activities related to this trial and be able to understand the procedures and methods of the trial. Be willing to strictly follow the clinical trial protocol to complete the trial.
• Healthy males or females aged 18-55 years (inclusive, as of signing the informed consent form).
• Body mass index (BMI) between 19 and 28 kg/m2 (inclusive), with a weight ≥ 50 kg.
• Have not used GLP-1 or its analogs, DPP Ⅳ inhibitors or its analogs, or other glucose-lowering drugs.

You may not qualify if:

• \. Subjects with any of the following conditions or medical history:
• Any clinical disease that the investigator determines may affect the safety or results of the study.
• Diagnosed with diabetes according to the WHO guidelines for the diagnosis and management of diabetes.
• A history of thyroid cancer or family history of thyroid cancer, a history of pancreatitis, or symptomatic gallstones.
• History of severe systemic infection within 1 month of screening.
• History of severe cardiovascular disease, including decompensated heart failure (NYHA class III or IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, or history of coronary artery bypass surgery or percutaneous coronary intervention.
• Subjects with clinically significant abnormal thyroid function at screening.
• Prolonged QTcF interval on screening or baseline ECG (male \> 450 ms, female \> 470 ms), or other clinically significant abnormalities that may result in a significant safety risk for the subjects.
• Subjects with severe mental disorders.
• \. Use of prescription drugs (topical eye/ nasal drops and ointments are allowed) and over-the-counter drugs, food supplements, vitamins, and Chinese herbs within 2 weeks before the start of treatment (routine vitamins are allowed).
• \. Any of the following:
• A history of recurrent or severe drug-food allergies, or known or suspected allergy to any component of the investigational drug.
• Participation in any drug clinical trial within the past 3 months (defined as receiving trial drug treatment).
• Consumption of more than 14 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of alcohol with a 40% alcohol content or 150 mL of wine) within the past 1 year, or a positive breath alcohol test.
• A history of smoking (≥5 cigarettes per day for the past 1 year) or a history of smoking in the past 1 year; subjects who cannot or are unwilling to abstain from smoking during the study period, or subjects who cannot use nicotine gum or transdermal nicotine patches.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a single-center, randomized, double-blind, placebo-controlled, crossover study. Healthy subjects were randomly assigned to receive SHR20004 or placebo treatment. In the group receiving SHR20004, the pharmacokinetic changes of acetaminophen were compared before and after treatment with SHR20004.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: December 26, 2023
• Primary Completion: March 16, 2024
• Study Completion: March 16, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-02

Locations

CN (1)