A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects

A Single Center, Phase I, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of TQB3101 in Healthy Subjects

Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetic Study
• Intervention / Treatment: Drug: TQ-B3101

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Zhongshan Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study;
• Subjects must be willing and able to communicate well, understand and follow the protocol required to complete the study;
• Males and females between 18 to 60 years of age
• Males and females with a body mass Index (BMI) range 19~26 kg/m2 inclusive, male subject not less than 50kg, female subject not less than 45kg。
• Male subjects must agree to use a medically acceptable method of contraception from Screening until 6 months after administration of the last dose of study drug
• Male subjects agrees not to donate sperm for at least 6 months after administration of the last dose of study drug
• Female subjects of non-childbearing potential measures, meeting at least one of the following criteria:①menorrhoeal for 12 months and FSH >40mIU/mL;② hysterectomy;③oophorectomy.
• Subjects who are healthy as determined by physical examination,vital signs, 12-Lead ECG and X-ray examination.

Exclusion Criteria:

• Subjects who have a history or presence of cardiovascular, neurological, endocrine, respiratory, hematological, immunological, psychiatric diseases or disorders that, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
• Subjects who have a history of relevant drug hypersensitivity or atopic allergic disease history(asthma,urticaria, eczema dermatitis).
• Current or recent (within 6 months of study drug administration) gastrointestinal , liver and kidney disease that could impact upon the absorption of study drug.
• Any major surgery within 4 weeks of study drug administration .
• Subjects who consume more than 14 units of alcohol per week during 3 months before drug administration, taken any alcohol-containing products within 24 hours ,or subjects who test negative alcohol at screening and admission
• Smokers who smoked more than 5 cigarettes before study drug administration,or can not quit smoking during the study.
• Subjects who test positive for drugs of abuse.
• Subjects who have donated blood or have a blood loss(≥300mL)within the previous 3 months prior to first dosing.
• Subjects who used any drugs that change liver enzyme activity,such as inhibitors or inducers of CYP3A4, P-gp or BCRP within 28days;
• Subjects who used any drugs including over thePrescription drugs, counter medications ,vitamin products herbal preparations.
• Subjects who have taken a special diet (including grapefruit, etc.) or exercised vigorously in the 14 days ,or other factors affecting drug absorption, distribution, metabolism, and excretion
• Participated in drug clinical trials within 3 months before taking the study ;
• Subjects with laboratory abnormalities,or or white blood cell count, neutrophil cell count and the percentage of the platelet count below the normal limit.
• Positive test result for HIV antibodies.
• Positive test for treponema Antibodies hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab).
• Subjects who have acute disease or concomitant medication at the time of screening and/or admission.
• Subjects who consuming chocolate, any caffeine-rich or xanthine-rich food or drink 24 hours before.
• The PI considered other factors unfit to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQ-B3101: Fed + Fast; In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fed condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fasted condition on Day 1 of treatment period 2.	Drug: TQ-B3101; TQ-B3101 oral capsule
Experimental: TQ-B3101: Fast+Fed; In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fed condition on Day 1 of treatment period 2.	Drug: TQ-B3101; TQ-B3101 oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	maximum concentration of the analyte in plasma	pre-dosing on Day 1 up to 144 hours post-dosing
Tmax	Time to Reach the Maximum Observed Plasma Concentration (Cmax) of the analyte	pre-dosing on Day 1 up to 144 hours post-dosing
AUC0-t	Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of the analyte	pre-dosing on Day 1 up to 144 hours post-dosing
AUC0-inf	Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time of the analyte	pre-dosing on Day 1 up to 144 hours post-dosing

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): July 3, 2021

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TQ-B3101-I-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No