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

NCT05316259 | Completed Phase 1

• 1 other identifier: BTP-66732FE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Tmax

  from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

• t1/2

  from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

• λz

  from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

• tlag

  from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

• AUC %Extrap

  from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

BPI-16350 DRUG

Administered orally

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100069, China

Location

Study Officials

• Haibin Yu, Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 7, 2022
• Study Start: April 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)