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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BPI-16350


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A（Dosing in the fasted state followed by fed dosing）<br>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<br>* Administered orally<br>|
| Experimental: Group B（Dosing in the fed state followed by fasted dosing）<br>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<br>* Administered orally<br>|

What is the study measuring?
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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 |