Health SubjectsPhase 1NCT06724549

The Effect of Food on the Pharmacokinetics of BN104 Tablets

A Phase 1 study testing BN104 in people with Health Subjects, run by BioNova Pharmaceuticals (Shanghai) LTD. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Health Subjects
What is being tested?: BN104
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 12 Jan 2025to 13 Feb 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

(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;

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(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;
(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;
(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;
(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;
(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;
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;
ECG results at screening showing QTcF > 450 ms (calculated using Fridericia's formula: QTcF = QT/(RR)1/3);
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.
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Xiangya Hospital of Central South University
Changsha, Hunan, 410008

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Health Subjects
Being tested: BN104

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BN104Drug
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.

Study groups in NCT06724549
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: BN104

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak concentration (Cmax)
Assess the Cmax of BN104 and its metabolite BNM-1263
Measured: 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
Measured: 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
Measured: 2 weeks

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202513 Feb 2025

First posted9 Dec 2024
Study start12 Jan 2025
Primary completion13 Feb 2025
Study completion13 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Health SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06724549
Sponsor's protocol ID: BN104-106
Status last verified: Dec 2024
First submitted: 2 Dec 2024
Last updated: 8 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effect of Food on the Pharmacokinetics of BN104 Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT06724549
Acronym / sponsor ID: BN104-106
Conditions: Health Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: BioNova Pharmaceuticals (Shanghai) LTD.Industry (pharma, biotech, devices)
Study start: 12 Jan 2025 (actual)
Primary completion: 13 Feb 2025 (actual)
Study completion: 13 Feb 2025 (actual)
First posted: 9 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasting-Fed	Active comparator	Drug: BN104Patients 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.
Fed-Fasting	Active comparator	Drug: BN104Patients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (23 listed)

(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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BN104This 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.	Drug	Fasting-Fed, Fed-Fasting

Primary outcome

Peak concentration (Cmax)
Time frame: 2 weeks
Assess the Cmax of BN104 and its metabolite BNM-1263
Auc(0-last）
Time frame: 2 weeks
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
Auc(0-∞）
Time frame: 2 weeks
Assess the area under the plasma concentration-time curve from time zero to infinity of BN104 and its metabolite BNM-1263

6 secondary outcomes

Time to maximum concentration (Tmax)
Time frame: 2 weeks
Elimination half-life (t½)
Time frame: 2 weeks
apparent clearance (CL/F)
Time frame: 2 weeks
apparent volume of distribution (Vz/F)
Time frame: 2 weeks
adverse events (AEs)
Time frame: 2 months
12-lead electrocardiograms (ECGs)
Time frame: 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BN104 in people with Health Subjects, run by BioNova Pharmaceuticals (Shanghai) LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak concentration (Cmax) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06724549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.