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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BPI-16350

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cmax	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	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-∞	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

Outcome Measure	Measure Description	Time Frame
Tmax	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	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	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	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	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	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	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	Number of subjects with treatment related adverse events	from Day 1 to Day 23

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Haibin Yu, Ph.D, Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID 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