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

Myelofibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982106
• Other study ID #: TQ05105-I-03
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2021
• Est. completion date: July 28, 2021

Study information

• Verified date: August 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

Drug:
• TQ05105 Tablets
TQ05105 tablet is a novel JAK2 inhibitor.

Locations

Country	Name	City	State
China	Affiliated Hospital of Changchun University of Traditional Chinese Medicine	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the drug-time curve (AUC)	Area under the drug-time curve	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
Primary	Maximum Concentration (Cmax)	Maximum concentration	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	Time to maximum concentration following drug administration (Tmax)	Time to maximum concentration following drug administration	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	Apparent terminal elimination half-life following drug administration (t1/2)	Apparent terminal elimination half-life following drug administration	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	Apparent volume of distribution (Vd/F)	Apparent volume of distribution	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	Clearance rate (CL/F)	Clearance rate	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	Adverse event rate	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).	Baseline up to 24 hours after administration
Secondary	Body temperature	Monitor the safety indicators of subjects during the trial	1 hour before administration and 1, 4, 12, 24 hours after administration
Secondary	Pulse	Monitor the safety indicators of subjects during the trial	1 hour before administration and 1, 4, 12, 24 hours after administration
Secondary	Blood pressure	Monitor the safety indicators of subjects during the trial	1 hour before administration and 1, 4, 12, 24 hours after administration