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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316259
• Other study ID #: BTP-66732FE
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2023
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BPI-16350
Administered orally

Locations

Country	Name	City	State
China	Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	AUC0-8	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	Tmax	Time to reach maximum observed plasma concentration	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	t1/2	Half-life time	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	?z	Elimination rate constant	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	tlag	Lag Time	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	AUC %Extrap	Percentage of AUCinf due to extrapolation from Tlast to infinity	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	CL/F	Apparent Oral Clearance	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	V/F	Apparent Volume of Distribution	from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Secondary	Characterize the safety of BPI-16350	Number of subjects with treatment related adverse events	from Day 1 to Day 23