Recruiting NCT07566572

A Study of BGM0504 Tablets in Healthy Chinese Subjects

Phase I Interventional Chinese Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BGM0504 tablets.
Who it may be relevant to: Registry conditions: Chinese Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.

Overview

A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.

Interventions

Drug BGM0504 tablets
Administered p.o.

Primary outcome measures

Pharmacokinetic (PK) endpoint： AUC0-tau,ss [Time frame: 4 weeks]
PK endpoint：Cmax,ss [Time frame: 4 weeks]
PK endpoint：t1/2,ss [Time frame: 4 weeks]

Secondary outcome measures (5)

Pharmacodynamics (PD) endpoint：Changes in fasting blood glucose [Time frame: 6 weeks]
PD endpoint：waist circumference before and after administration [Time frame: 6 weeks]
PD endpoint：body weight before and after administration [Time frame: 6 weeks]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 6 weeks]
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;

weight ≥ 50 kg, and body mass index (BMI): 24.0 kg/m² ≤ BMI < 30 kg/m²（BMI = weight/height²）;
(Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
Participants should be willing to take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration, and have no plans for sperm or egg donation.
Participants who were determined to be generally healthy by the investigator based on their past medical history, physical examination, vital signs, laboratory tests and electrocardiogram examinations.

Exclusion criteria

● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution;

(Medical Inquiry) Individuals who have previously suffered from or currently have major diseases in the nervous system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, blood system or immune system, and are judged by the investigator to be unsuitable to participate in this trial;
(Examination) Any laboratory test results judged by the investigator as abnormal and of clinical significance;
(Medical Inquiry/Examination) Individuals who previously had obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), affected gastric emptying (such as pyloric stenosis), or had undergone any gastrointestinal surgery (except for intestinal polyp resection and appendectomy), or had acute diarrhea, constipation within the 7 days before randomization; Diarrhea is defined as watery stools and/or daily defecation ≥ 3 times. Constipation is defined as the inability to achieve at least one defecation per day;
(Medical Inquiry/Examination) During the screening, individuals with acute cholecystitis, chronic cholecystitis; or those with symptomatic or treatable gallstones at the time of screening; or those with symptomatic or treatable gallbladder polyps at the time of screening;
(Medical Inquiry) Individuals previously diagnosed with thyroid C-cell carcinoma, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or with a related family history;
(Medical Inquiry) Individuals previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;
(Medical Inquiry/Query) Individuals who used any prescription drugs or over-the-counter drugs (including chemical drugs, vitamin drugs, herbal drugs, etc.) within 2 weeks before screening;
(Examination) Individuals with any positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody during the screening period;
(Examination) At the screening/baseline, 12-lead electrocardiogram shows a heart rate of < 50 beats per minute or > 100 beats per minute, second or third degree atrioventricular conduction block, long QT syndrome or for women QTcF > 470 ms or for men > 450 ms or other electrocardiogram abnormalities judged by the investigator as requiring drug intervention;
(Medical Inquiry) Individuals with a history of fainting during blood transfusion or needle phobia;
(Medical Inquiry) Individuals who have taken drugs or had drug abuse history within 6 months before screening;
(Medical Inquiry) Individuals who smoked more than 10 cigarettes per day on average (including nicotine replacement products) within 3 months before screening, or who could not prohibit smoking throughout the trial stay;
(Medical Inquiry) Individuals who frequently drank alcohol within the 3 months before screening, that is, with an average daily alcohol intake of more than 2 units (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL alcohol for 5% beer or 43 mL alcohol for 40% liquor or 147 mL alcohol for 12% wine) or who could not abstain from alcohol throughout the trial stay;
(Medical Inquiry) Individuals who donated blood or lost more than 400 mL of blood within 3 months before screening or plan to donate blood during or after the trial;
(Medical Inquiry/Query) Individuals who participated in drug or medical device clinical trials and received trial drugs (except for placebo) or medical device interventions within 3 months before screening;
(Medical Inquiry) Individuals who received any vaccine or plan to receive a vaccine during screening;
(Medical Inquiry/Examination) Female participants who are pregnant or lactating, or those with positive pregnancy test results during the screening period;
(Examination) Individuals with positive urine drug or alcohol breath screening at the baseline period;
Individuals determined by the investigator to be unsuitable to participate in this study or who withdrew from the study for personal reasons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

China · 1 center

Hangzhou First People's Hospital — Hangzhou

Identifiers

NCT: NCT07566572 · BGM0504-CPK-102

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗