The Effect of Food on the Pharmacokinetics of BN104 Tablets

NCT06724549 | Completed Phase 1

• 1 other identifier: BN104-106
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Time to maximum concentration (Tmax)

  2 weeks

• Elimination half-life (t½)

  2 weeks

• apparent clearance (CL/F)

  2 weeks

• apparent volume of distribution (Vz/F)

  2 weeks

• adverse events (AEs)

  2 months

Study Arms (2)

Fasting-Fed

ACTIVE COMPARATOR

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

Fed-Fasting

ACTIVE COMPARATOR

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

Interventions

BN104 DRUG

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.

Fasting-Fed; Fed-Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male or female;
• 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);
• 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.

You may not qualify if:

• (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;
• (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;
• (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;
• (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;
• (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;
• (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;
• (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;
• (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;
• (Inquiry) Individuals who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
• (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;
• (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;
• (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;
• (Inquiry) Those who have special requirements for diet and cannot follow a unified diet;
• (Inquiry) Those with dysphagia;
• (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;

Sponsors & Collaborators

• BioNova Pharmaceuticals (Shanghai) LTD.: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, 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

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: January 12, 2025
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: August 8, 2025

Record last verified: 2024-12

Locations

CN (1)