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

NCT ID: NCT05316259

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2022-08-30

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BPI-16350

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

BPI-16350

Intervention Type: DRUG

Administered orally

Interventions

BPI-16350

Administered orally

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haibin Yu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BTP-66732FE

Identifier Type: -

Identifier Source: org_study_id