The Effect of Food on the Pharmacokinetics of BN104 Tablets

A Study to Evaluate the Effect of Food on the Pharmacokinetics of BN104 Tablets in Healthy Subjects

The goal of the clinical trial is to evaluate the effect of food on the Pharmacokinetics of BN104 tablets in healthy subjects. The main questions it aims to answer are:

Whether the pharmacokinetic characteristics of BN104 tablets will be affected by food? How well is the safety and tolerability of BN104 tablets in healthy subjects? To preliminarily evaluate the effect of BN104 on the QTc interval.

Study Overview

• Status: Completed
• Conditions: Health Subjects
• Intervention / Treatment: Drug: BN104

Detailed Description

This study adopted a single-center, randomized, open-label, single-dose, two-treatment (fasting or following a high-fat meal), two-period, and two-sequence crossover design. A total of 16 healthy subjects were enrolled in this trial. The subjects were randomized two days before dosing, and the subjects were randomly assigned to the fasting to high-fat meal group or the high-fat meal to fasting group with 8 subjects in each group. The single-dose regimen was adopted in this study, and the washout period between the periods was 7 days.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

1. Age ≥ 18 years, male or female;
2. Male subjects weighed ≥ 50.0 kg and female subjects weighed ≥45.0 kg, with a body mass index (BMI) between 19 and 26 kg/m2 (both inclusive);
3. Subjects must fully understand the purpose, nature, methods, and potential adverse reactions of the study and voluntarily consent to participate. Prior to any study procedures, subjects must provide written informed consent and ensure their personal participation in all study-related procedures.

Exclusion Criteria:

1. (Inquiry) A history or current presence of clinically significant diseases affecting the circulatory, endocrine, nervous, gastrointestinal, respiratory systems, or hematologic, immunologic, psychiatric, or metabolic disorders, or any other conditions (e.g., heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome) that could interfere with study outcomes;
2. (Inquiry) Those who have any history of allergy to two or more drugs, food, or other substances, or are allergic to any of the components of the investigational drug;
3. (Inquiry) Those who have undergone surgery within 28 days prior to the first dose of the investigational drug or who plan to have surgery during the trial;
4. (Inquiry) Those who have been vaccinated 1 month before the first administration of the investigational drug, or those who plan to be vaccinated during the trial;
5. (Inquiry) Those who have received any medications or health care products (including Chinese Herbal Medicine) within 14 days prior to the first dose of the investigational drug;
6. (Inquiry) Use of any drugs that may influence the pharmacokinetics of the investigational drug within 30 days prior to the first dose, including: strong CYP3A4 inhibitors: e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, ritonavir, indinavir, voriconazole; moderate CYP3A4 and/or P-glycoprotein (P-gp) inhibitors: e.g., fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem; strong CYP3A4 inducers: e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort;
7. (Inquiry) Those who have received any clinical trial drug or enrolled in any drug/medical device clinical trial within 3 months prior to the first dose of investigational drug;
8. (Inquiry) Blood donors who have donated blood within 3 months prior to the first dose of investigational drug, or those who have lost more than 400 mL of blood within 3 months prior to the first dose of investigational drug;
9. (Inquiry) Individuals who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
10. (Inquiry) Those who have received oral contraceptives within 30 days prior to the first dose of investigational drug or who have received long-acting estrogen or progestin injections or implants within 6 months prior to the first dose of investigational drug;
11. (Inquiry) Those who have had unprotected sex within 14 days prior to the first dose of the investigational drug (females), or females who are pregnant or breastfeeding;
12. (Inquiry) Those who cannot take at least 1 non-medication contraceptive measure with the partner throughout the trial, or those who plan to bear a child, donate sperm, or donate egg within 3 months after the study completion;
13. (Inquiry) Those who have special requirements for diet and cannot follow a unified diet;
14. (Inquiry) Those with dysphagia;
15. (Inquiry) Those who have consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day during the 3 months prior to the first dose of the investigational drug;
16. (Inquiry) Those who have ingested or plan to ingest any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) or foods (e.g., sardines, animal livers, etc.) or beverages that are rich in xanthine components within 48 hours prior to the first dose of study drug;
17. (Inquiry) Those who have consumed foods that can affect the in vivo metabolism of the drug (including citrus fruits such as grapefruit, lime, and pomelo, and pitaya, mango, carambola, papaya, and pomegranate, etc.), or other foods that can affect drug absorption, distribution, metabolism, or excretion within 7 days before the first dose of the investigational drug and considered as not suitable to participate in the trial by the investigator; or those who refuse to discontinue such diet during the trial;
18. (Inquiry) Addicted to smoking, daily smoking of more than five cigarettes within three months prior to the first dose, or inability to discontinue smoking of any tobacco products during this trial;
19. (Inquiry) Alcoholics or regular drinkers within the 6 months before the first dose of the investigational drug, i.e., more than 14 units of alcohol per week (1 unit of ≈ 200 mL of beer with 5% alcohol content or 25 mL of spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content), or those unable to abstain from alcohol during the study;
20. Screening results showing ALT > 1.5×ULN and/or AST > 1.5×ULN and/or bilirubin > 1.5×ULN for liver function and/or creatinine > 1.0×ULN for renal function;
21. ECG results at screening showing QTcF > 450 ms (calculated using Fridericia's formula: QTcF = QT/(RR)1/3);
22. Those with any clinically significant abnormalities in vital signs, physical examination, ECG, or laboratory tests, as judged by the study doctor, that could pose increased safety risks if participating in the study.
23. Those who may not be able to complete this trial for other reasons or who shall not be included in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fasting-Fed; Patients will be administrated 600mg dose of BN104 tablets under fasting conditions and fed conditions in period 1 and 2 respectively. There will be a at least 7-day washout period between the first and second dose.	Drug: BN104; This study adopts two-treatment (fasting or following a high-fat meal), two-period, two-sequence crossover design. The subjects will be randomly assigned into one of two treatment sequences in a 1:1 ratio. A single 600 mg dose of BN104 tablets administered under fasting conditions or after a standard high-fat breakfast in period 1 and 2.
Active Comparator: Fed-Fasting; Patients will be administrated 600mg dose of BN104 tablets under fed conditions and fasting conditions in period 1 and 2 respectively. There will be a at least 7-day washout period between the first and second dose.	Drug: BN104; This study adopts two-treatment (fasting or following a high-fat meal), two-period, two-sequence crossover design. The subjects will be randomly assigned into one of two treatment sequences in a 1:1 ratio. A single 600 mg dose of BN104 tablets administered under fasting conditions or after a standard high-fat breakfast in period 1 and 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	Assess the Cmax of BN104 and its metabolite BNM-1263	2 weeks
Auc(0-last）	Assess the area under the plasma concentration-time curve from time zero to the last quantifiable time point of BN104 and its metabolite BNM-1263	2 weeks
Auc(0-∞）	Assess the area under the plasma concentration-time curve from time zero to infinity of BN104 and its metabolite BNM-1263	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum concentration (Tmax)	Assess the Tmax parameters of BN104 and its metabolite BNM-1263	2 weeks
Elimination half-life (t½)	Assess the elimination half-life (t½) parameters of BN104 and its metabolite BNM-1263	2 weeks
apparent clearance (CL/F)	Assess the apparent clearance (CL/F) parameters of BN104 and its metabolite BNM-1263	2 weeks
apparent volume of distribution (Vz/F)	Assess the apparent volume of distribution (Vz/F) parameters of BN104 and its metabolite BNM-1263	2 weeks
adverse events (AEs)	Assess the incidence and grade of AEs	2 months
12-lead electrocardiograms (ECGs)	Assess the correlation between plasma concentrations of BN104 and QTc interval.	2 months

Collaborators and Investigators

• Sponsor: BioNova Pharmaceuticals (Shanghai) LTD.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2025
• Primary Completion (Actual): February 13, 2025
• Study Completion (Actual): February 13, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BN104-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No