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

Betta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BPI-16350

Study type: Interventional

Funder types: Industry

Identifiers

NCT05316259

BTP-66732FE

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group A（Dosing in the fasted state followed by fed dosing）

Experimental group

Description:

Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.

Treatment:

Drug: BPI-16350

Group B（Dosing in the fed state followed by fasted dosing）

Experimental group

Description:

Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.

Treatment:

Drug: BPI-16350