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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BPI-16350

• Registration Number: NCT05316259
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-04-15
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A（Dosing in the fasted state followed by fed dosing）	BPI-16350	Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
Group B（Dosing in the fed state followed by fasted dosing）	BPI-16350	Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.

Primary Outcome Measures

Name	Time	Method
Cmax	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose	Maximum observed concentration
AUC0-t	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
AUC0-∞	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

Secondary Outcome Measures

Name	Time	Method
t1/2	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose	Half-life time
Tmax	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
λz	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose	Elimination rate constant
tlag	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose	Lag Time
V/F	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
AUC %Extrap	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
CL/F	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose	Apparent Oral Clearance
Characterize the safety of BPI-16350	from Day 1 to Day 23	Number of subjects with treatment related adverse events

Trial Locations

Locations (1)

Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China