Clinical trial NCT05316259: A Food-Effect Study of BPI-16350 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


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.

Primary outcomes:
measure: Cmax
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: AUC0-t
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: AUC0-∞
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary outcomes:
measure: Tmax
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: t1/2
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: λz
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: tlag
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: AUC %Extrap
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: CL/F
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: V/F
timeFrame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
measure: Characterize the safety of BPI-16350
timeFrame: from Day 1 to Day 23
Other outcomes:
Locations:
city: Beijing
country: China
facility: Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University
name: Haibin Yu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: