Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males

Zenshine Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Respiratory Viral Infection

Treatments: Other: ZX-7101A tablet; Drug: ZX-7101A dry suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT06841926

ZX-7101A-213

Details and patient eligibility

About

Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males

Full description

To evaluate the pharmacokinetic profile and relative bioavailability of the active metabolite ZX-7101 (parent drug) after a single oral administration of 40 mg ZX-7101A for suspension and 40 mg ZX-7101A tablet in healthy Chinese adult male subjects

Enrollment: 40 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects aged 18 to 45 years (including the cut-off value, subject to the signing of the informed consent)
• Body mass index (BMI) of 19 to 26 kg/m2 (including the cut-off value), with a body weight of at least 50 kg
• Based on the medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), viral serology and chest X-ray results, the investigator judged that the subjects were in good general health (normal or abnormal examination results were not clinically significant).
• Voluntary informed consent, no fertility and sperm donation plans within 90 days after the last dose of medication, and voluntary use of highly effective contraception (including a partner) (Nonpharmacologic contraception was required during the clinical trial)
• Before signing the informed consent, the patients should have a full understanding of the trial content, process and possible adverse reactions, and voluntarily sign the informed consent.
• Be able to complete the study in accordance with the protocol requirements

Exclusion criteria

• Allergic (multiple drug and food allergies) or those who are likely to be allergic to the investigational drug or any component of the investigational drug as judged by the investigator;
• Subjects with taste and smell dysfunction
• Oral ulcer or mucosal injury
• Subjects with a previous or present medical history of clinically abnormal metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurologic, or psychiatric disease who were deemed by the investigator to be ineligible for participation in the study
• Subjects whose vital signs were abnormal and clinically significant before administration
• Subjects with abnormal white blood cell or neutrophil count before administration that was judged by the investigators to be clinically significant;
• Before administration, the subjects had abnormal liver function: total bilirubin >1.5× upper limit of normal (ULN), AST >1.5× ULN, ALT >1.5× ULN;
• Estimated glomerular filtration rate <90 mL/min/1.73 m2 (eGFR formula)
• QTc interval > 450ms (Fridericia's correction, QTcF=QT/(RR^0.33)), QRS>120ms
• Acute respiratory infection within 2 weeks before the study
• Subjects who have difficulty swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, etc.); Or have a history of gastrointestinal surgery or resection that may alter the absorption and/or excretion of oral medications (subjects who have undergone appendectomy may be included)
• Use of any prescription drug or Chinese herbal medicine within 4 weeks before trial initiation and use of over-the-counter or nutrual products (including multivalent cations, inhibitors, and metal supplements) within 2 weeks before trial initiation would require a longer interval of at least 5 half-ages of the drug
• Subjects who had consumed more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) in the 6 months before screening or had received a positive breath test for alcohol
• Smoking more than five cigarettes per day or habitual use of nicotine-containing products in the 3 months before screening.
• Subjects who were unwilling to abstain from foods or drinks containing caffeine or alcohol that affect drug metabolism within 72 hours before drug administration and during the period of observation in phase I ward.
• Use of any known liver enzyme inducer or liver enzyme inhibitor (grapefruit, orange juice, etc.) within 14 days before administration.
• Subjects with a history of drug abuse (morphine, dimethyldioxyamphetamine, methamphetamines, tetrahydrocannabinol, ketamine, cocaine) or screening positive for drug abuse;
• Subjects who were serologically positive for syphilis antibody (TP-trust), hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody;
• Donating >400 mL within 3 months or >200 mL within 4 weeks prior to the screening period or planning to donate during the study period;
• Those who have difficulty in venous blood collection;
• Subjects who participated in other clinical trials or used any other clinical trial drugs or devices within 3 months before screening;
• Vaccinated within 1 month prior to dose or planned to be vaccinated during the study period;
• Subjects who had a surgical procedure within 6 months before screening or who were scheduled to undergo surgery during the trial;
• Any other situation that the investigator considers may affect the subject's provision of informed consent or compliance with the trial protocol or completion of the trial according to the study process, or the subject's participation in the trial may affect the trial results or their own safety.Subjects who were serologically positive for syphilis antibody (TP-trust), hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

The test preparation was followed by the reference preparation

Other group

Description:

Group 1: The test preparation was followed by the reference preparation: 20 subjects were given the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) orally in the first cycle, and crossed over to the reference formulation ZX-7101A tablets 40 mg (1 tablet) in the second cycle, with a wash period of at least 21 days between two weeks.

Treatment:

Drug: ZX-7101A dry suspension

Other: ZX-7101A tablet

The reference preparation was followed by the test preparation

Other group

Description:

Group 2: The reference preparation was followed by the test preparation: 20 subjects were given reference formulation ZX-7101A tablets 40 mg (1 tablet) orally in the first cycle, and crossed over to the the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) in the second cycle, with a wash period of at least 21 days between two weeks.

Treatment:

Drug: ZX-7101A dry suspension

Other: ZX-7101A tablet