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

NCT06841926 | Completed Phase 1

• 1 other identifier: ZX-7101A-213
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (4)

• The pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug)

  Pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets

  From Day1 up to Day 36

• The pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug)

  Pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets

  From Day1 up to Day 36

• The pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug)

  Pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets

  From Day1 up to Day 36

• Relative bioavailability of the active metabolite ZX-7101 (parent drug)

  Relative bioavailability of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets.

  From Day1 up to Day 36

Secondary Outcomes (10)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  From Day 1 up to Day 36

• Cmax

  From Day 1 up to Day 36

• AUC0-t

  From Day 1 up to Day 36

• AUC0-inf

  From Day 1 up to Day 36

• Evaluation of palatability

  On Day 1

Study Arms (2)

The test preparation was followed by the reference preparation

OTHER

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.

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

The reference preparation was followed by the test preparation

OTHER

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.

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

Interventions

ZX-7101A dry suspension DRUG

Test formulation (T) : ZX-7101A dry suspension Specification: 10 mg/ bag Dosage：40 mg (4 bags)、 once

The reference preparation was followed by the test preparation; The test preparation was followed by the reference preparation

ZX-7101A tablet OTHER

Reference formulation (R): ZX-7101A tablet Specification: 40 mg/ tablet Dosage：40 mg (1 tablet)、 once

The reference preparation was followed by the test preparation; The test preparation was followed by the reference preparation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (1)

West China Second University Hospital, Sichuan University and Children's Hospital Zhejiang University School of Medicine

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was a single-center, randomized, open-label, two-dose, two-cycle, two-sequence, double-crossover design. A total of 40 healthy male subjects were randomly divided into 2 sequences, 20 subjects in each sequence. Subjects received 40 mg of test preparation ZX-7101A dry suspension (4 bags) or 40 mg of reference preparation ZX-7101A tablets (1 tablet) per cycle. Subjects received either the test formulation (T) or the reference formulation (R) orally in the first cycle according to their random allocation of subjects, and crossed over to the reference formulation (R) or the test formulation (T) in the second cycle. The cleaning period was at least 21 days between the two weeks.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 24, 2025
• Study Start: February 20, 2025
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)