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To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects

Primary Purpose

Myelofibrosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQ05105 Tablets
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myelofibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1 Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2 Able to communicate well, understand and complete the research in accordance with the requirements of the experimental protocol; 3 Male and female subjects aged 18 to 65 (including 18 and 65 years old); 4 Body mass index (BMI) ≥ 18 and ≤ 28kg/m2, and male weight ≥ 50 kg and female weight ≥ 45 kg; 5 Health status: no history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities, and physical examination showed normal or abnormal blood pressure, heart rate, electrocardiogram, respiratory system, liver, kidney function and blood picture without clinical significance; 6 The subjects have no pregnancy plans and voluntarily take effective contraceptive measures from 2 weeks before the administration to at least 6 months after the last use of the study drug. Exclusion Criteria: 1 Patients with neuropsychiatric system, respiratory system, cardiovascular system, digestive tract system, blood-lymphatic system, liver and kidney insufficiency, endocrine system, musculoskeletal system disease or other diseases in the past, and the researcher judges that the past medical history may have an adverse effect on the drug. Metabolic or safety effects; 2 Those with allergic constitution or a history of two or more food or drug allergies in the past; 3 Those with multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal diseases); 4 Taking any prescription, over-the-counter, vitamin product or herbal medicine within 1 month before taking the study drug; 5 Take CYP3A4 inhibitors or inducers within 1 month before screening or before study medication; 6 Those who have taken special diets (including grapefruit, etc.) or exercised vigorously within 14 days before screening, or have other factors that affect drug absorption, distribution, metabolism, and excretion; 7 aboratory examinations during the screening period are abnormal and have clinical significance; 8 Blood donation or massive blood loss (> 450mL) within 3 months before taking the study drug; 9 Participated in any drug clinical trial within 3 months before taking the study drug; 10 Smoking more than 5 cigarettes per day within 3 months before the test; 11 Positive breath test for alcohol or a history of alcohol abuse within 2 weeks before screening (drinking 14 units of alcohol per week: 1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine); 12 Those who are positive for drug screening or have used drugs in the 3 months before the test; 13 Inability to tolerate venipuncture for blood collection or poor vascular condition; 14 Subjects have a history of herpes zoster within 1 month before screening; 15 The subject is unable to complete the trial due to personal reasons; 16 Other investigators deem it unsuitable for enrollment.

Sites / Locations

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TQ05105 Tablets (fasted)

TQ05105 Tablets (fed)

Arm Description

TQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B.

TQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B.

Outcomes

Primary Outcome Measures

Area under the drug-time curve (AUC)
Area under the drug-time curve
Maximum Concentration (Cmax)
Maximum concentration

Secondary Outcome Measures

Time to maximum concentration following drug administration (Tmax)
Time to maximum concentration following drug administration
Apparent terminal elimination half-life following drug administration (t1/2)
Apparent terminal elimination half-life following drug administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Clearance rate (CL/F)
Clearance rate
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Body temperature
Monitor the safety indicators of subjects during the trial
Pulse
Monitor the safety indicators of subjects during the trial
Blood pressure
Monitor the safety indicators of subjects during the trial

Full Information

First Posted
July 7, 2023
Last Updated
August 1, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05982106
Brief Title
To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects
Official Title
A Randomized, Open-label, Single-center, Two-cycle, Two-crossover Phase I Clinical Trial Evaluating the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 (JAK2)inhibitor and can be used to treat JAK2 target-related diseases. This study is a randomized, open-label, single-center, two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and safety after oral administration of TQ05105 tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TQ05105 Tablets (fasted)
Arm Type
Experimental
Arm Description
TQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B.
Arm Title
TQ05105 Tablets (fed)
Arm Type
Experimental
Arm Description
TQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B.
Intervention Type
Drug
Intervention Name(s)
TQ05105 Tablets
Intervention Description
TQ05105 tablet is a novel JAK2 inhibitor.
Primary Outcome Measure Information:
Title
Area under the drug-time curve (AUC)
Description
Area under the drug-time curve
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Title
Maximum Concentration (Cmax)
Description
Maximum concentration
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Secondary Outcome Measure Information:
Title
Time to maximum concentration following drug administration (Tmax)
Description
Time to maximum concentration following drug administration
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Title
Apparent terminal elimination half-life following drug administration (t1/2)
Description
Apparent terminal elimination half-life following drug administration
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Title
Apparent volume of distribution (Vd/F)
Description
Apparent volume of distribution
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Title
Clearance rate (CL/F)
Description
Clearance rate
Time Frame
1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 24 hours after administration
Title
Body temperature
Description
Monitor the safety indicators of subjects during the trial
Time Frame
1 hour before administration and 1, 4, 12, 24 hours after administration
Title
Pulse
Description
Monitor the safety indicators of subjects during the trial
Time Frame
1 hour before administration and 1, 4, 12, 24 hours after administration
Title
Blood pressure
Description
Monitor the safety indicators of subjects during the trial
Time Frame
1 hour before administration and 1, 4, 12, 24 hours after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1 Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2 Able to communicate well, understand and complete the research in accordance with the requirements of the experimental protocol; 3 Male and female subjects aged 18 to 65 (including 18 and 65 years old); 4 Body mass index (BMI) ≥ 18 and ≤ 28kg/m2, and male weight ≥ 50 kg and female weight ≥ 45 kg; 5 Health status: no history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities, and physical examination showed normal or abnormal blood pressure, heart rate, electrocardiogram, respiratory system, liver, kidney function and blood picture without clinical significance; 6 The subjects have no pregnancy plans and voluntarily take effective contraceptive measures from 2 weeks before the administration to at least 6 months after the last use of the study drug. Exclusion Criteria: 1 Patients with neuropsychiatric system, respiratory system, cardiovascular system, digestive tract system, blood-lymphatic system, liver and kidney insufficiency, endocrine system, musculoskeletal system disease or other diseases in the past, and the researcher judges that the past medical history may have an adverse effect on the drug. Metabolic or safety effects; 2 Those with allergic constitution or a history of two or more food or drug allergies in the past; 3 Those with multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal diseases); 4 Taking any prescription, over-the-counter, vitamin product or herbal medicine within 1 month before taking the study drug; 5 Take CYP3A4 inhibitors or inducers within 1 month before screening or before study medication; 6 Those who have taken special diets (including grapefruit, etc.) or exercised vigorously within 14 days before screening, or have other factors that affect drug absorption, distribution, metabolism, and excretion; 7 aboratory examinations during the screening period are abnormal and have clinical significance; 8 Blood donation or massive blood loss (> 450mL) within 3 months before taking the study drug; 9 Participated in any drug clinical trial within 3 months before taking the study drug; 10 Smoking more than 5 cigarettes per day within 3 months before the test; 11 Positive breath test for alcohol or a history of alcohol abuse within 2 weeks before screening (drinking 14 units of alcohol per week: 1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine); 12 Those who are positive for drug screening or have used drugs in the 3 months before the test; 13 Inability to tolerate venipuncture for blood collection or poor vascular condition; 14 Subjects have a history of herpes zoster within 1 month before screening; 15 The subject is unable to complete the trial due to personal reasons; 16 Other investigators deem it unsuitable for enrollment.
Facility Information:
Facility Name
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130103
Country
China

12. IPD Sharing Statement

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To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects

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