A Food-Effect Study of BPI-16350 in Healthy Subjects

May 7, 2023 updated by: Betta Pharmaceuticals Co., Ltd.

A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100069
        • Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects aged 18~45 (including 18 and 45 years old);
  • Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
  • Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
  • The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
  • Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria:

  • History of significant hypersensitivity to any drug compound or food；
  • Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
  • Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
  • Family history of long QTc syndrome; History or presence of an abnormal ECG；
  • Drug abusers, smokers or alcoholics；
  • Use of any medications within 14 days prior to the first administration；
  • Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
  • Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
  • Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A（Dosing in the fasted state followed by fed dosing）
Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
Drug: BPI-16350
Administered orally
Experimental: Group B（Dosing in the fed state followed by fasted dosing）
Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
Drug: BPI-16350
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Maximum observed concentration
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC0-t
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Area under the concentration-time curve from time 0 to time t
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC0-∞
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Area under the concentration-time curve from time 0 to infinity
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Time to reach maximum observed plasma concentration
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
t1/2
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Half-life time
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
λz
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Elimination rate constant
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
tlag
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Lag Time
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC %Extrap
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Percentage of AUCinf due to extrapolation from Tlast to infinity
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
CL/F
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Apparent Oral Clearance
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
V/F
Time Frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Apparent Volume of Distribution
from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Characterize the safety of BPI-16350
Time Frame: from Day 1 to Day 23
Number of subjects with treatment related adverse events
from Day 1 to Day 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Betta Pharmaceuticals Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haibin Yu, Ph.D, Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTP-66732FE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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