A Study of AL8326 in Healthy Subjects (NCT07132957) | Clinical Trial Compass
CompletedPhase 1
A Study of AL8326 in Healthy Subjects
China6 participantsStarted 2025-02-21
Plain-language summary
This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of \[14C\] AL8326 oral formulation containing approximately 60mg (200 μ Ci). During the experiment, whole blood, plasma, urine, and fecal samples were collected at designated time points/time periods.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Chinese healthy male subjects, 18 to 45 years of age (inclusive)
✓. Body mass index (BMI) of 19-26 kg/m2 (inclusive), and body weight not less than 50 kg (inclusive)
✓. Subjects who had no fertility or sperm donation plan from signing the informed consent until 1 year after the end of the trial, or those who agreed that the subjects and their partners should strictly use contraception from signing the informed consent until 1 year after the end of the trial; Voluntarily signing the ICF，Ability to communicate well with the investigator and compliance to complete the trial according to the protocol.
Exclusion criteria
✕. Clinically significant abnormality of physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, coagulation, urinalysis, and stool routine + occult blood), 12-lead ECG, chest X-ray (anterograde), digital anal examination, thyroid function,ophthalmic examination and abdomen ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), etc.
✕. Subjects with an allergic constitution, such as known allergic history to two or more substances, or allergic diseases, or those who may be hypersensitive to the investigational drug or its excipients, as judged by the investigator;
✕. Gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome; Or a history of severe vomiting or diarrhea within one week before the screening period;
✕. History of dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy);
✕. History of any clinical critical illness or presence of diseases or conditions that the investigator considers may affect the trial results, including but not limited to diseases of digestive system, circulatory system, respiratory system, endocrine system, nervous system, urinary system or blood, immune system, psychiatric system and metabolism and nutrition diseases ;
What they're measuring
1
Material balance
Timeframe: All excreted urine and feces samples at specified time points during 0-480 hours after dosing will be collected.
2
Metabolites
Timeframe: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
3
Metabolites
Timeframe: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol
4
Pharmacokinetic
Timeframe: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol
5
whole blood
Timeframe: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol
✕. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or family history (genetic proof or sudden death of a close relative at a young age);
✕. Major surgery within 6 months before screening or incomplete healing of surgical incision, the major surgeries including but not limited to any procedures that have significant risk of hemorrhage, prolonged general anesthesia, open biopsy, or marked traumatic invasive injury;
✕. History of active bleeding (e.g., peptic ulcer, intracranial hemorrhage, skin ecchymosis, gingival bleeding); History of any disease within the previous 6 months that may increase the risk of bleeding (such as tumor bleeding, spontaneous hematoma, eye bleeding, hemoptysis, gastrointestinal bleeding or ulcers,hematuria,reproductive system bleeding, traumatic hematoma/bleeding, and frequent epistaxis/gingival bleeding/subcutaneous or skin bleeding) were screened.