A Drug-drug Interaction Study of YZJ-1139 Tablets and Ticagrelor Tablets in Healthy Subjects

Drug Interaction Study of YZJ-1139 Tablets With Ticagrelor Tablets

Primary Objective :

To evaluate the effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects;

Secondary Objective:

To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: YZJ-1139 tablets; Drug: Ticagrelor Tablets

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Huangzhou, China
    • Shulan (Hangzhou) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects who are able to understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form; 2) Male and female subjects aged 18~45 years (including cut-off value); 3) Male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (BMI) within the range of 19.0~26.0kg/m2 (including the cut-off value); 4) normal or abnormal physical examination, vital signs, 12-lead ECG, laboratory tests are not clinically significant; 5) Good health, those who with no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, psychiatric system history of serious and chronic diseases; 6) Subjects (including partners) have no fertility plan, sperm/egg donation plan and voluntarily use adequate contraception from signing informed consent and within 3 months after the last dose.

Exclusion Criteria:

1. Allergies: Those with a history of two or more drug or food allergies in the past; or those who are known to be allergic to YZJ-1139 tablets and test concomitant drugs and excipients;
2. Those who have difficulty swallowing tablets, or those who have special dietary requirements and cannot accept the standard diet provided by the research center;
3. Those who cannot tolerate venipuncture, or have a history of fainting blood or needles;
4. Those who have a history or current narcolepsy, obstructive sleep apnea, complex sleep behaviors (such as sleepwalking, dream driving, etc.), severe unconscious hypoglycemia, stroke, epilepsy and other psychiatric neurological diseases (including anxiety, depression, etc.), convulsive diseases, cataplexy;
5. Those with bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent intestinal bleeding), have a history of active pathological bleeding, intracranial hemorrhage, or other diseases that can change or increase bleeding tendency (peptic ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.);
6. Those who with abnormal clinical significance in the determination of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus (HIV) antigen antibody combined detection, and treponema pallidum specific antibody determination;
7. Regular drinkers within 6 months prior to screening, i.e., drinking an average of more than 14 units of alcohol per week (1 unit ≈ 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine) or > alcohol breath test results during the screening period0mg/100mL;
8. Those who have used soft drugs (such as marijuana) within 3 months before screening or taken hard drugs (such as cocaine, amphetamines, phencyclidine ) within 1 year before screening; or those with a history of substance abuse; or those who have a positive drug abuse screen at screening;
9. Those who have smoked ≥5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial;
10. Those who have donated blood or lost a large amount of blood (> 400mL) within 3 months prior to screening, received blood transfusion or used blood products;
11. Those who have participated in any clinical trial and been given investigational drugs or investigational medical devices within 3 months prior to screening; or those who plan to participate in other clinical trials during the study period;
12. Those who have undergone surgical procedures within 30 days prior to screening, or who plan to undergo surgical procedures during the study;
13. Received vaccination within 30 days prior to screening, or planned vaccination during the trial;
14. Use of any drug that inhibits or induces hepatic metabolism of the drug within 28 days prior to screening (e.g.: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines);
15. Those who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, or Chinese herbal medicines within 14 days before screening;
16. Consumption of grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before screening;
17. Intake of caffeine- or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, cola, etc.) within 24 hours before administration;
18. Female subjects who are lactating or have a positive pregnancy result;
19. Those who have sudden acute illness or new concomitant medication from the screening stage to before enrollment;
20. In the opinion of the investigator, the subject is not suitable for inclusion in this trial for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: YZJ-1139 tablets; Oral dose 20 mg; Drug: Ticagrelor Tablets; Oral dose 90 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of YZJ-1139(Cmax)	To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Maximum observed concentration (Cmax).	48 hours
Pharmacokinetics of YZJ-1139 (AUC0-∞)	To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) from time zero to infinity.	48 hours
Pharmacokinetics of YZJ-1139 (AUC0-t)	To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	The safety and tolerability of YZJ-1139 alone and in combination with ticagrelor will be examined.	13 days

Collaborators and Investigators

• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Actual): September 13, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: YZJ-1139-1-13

Drug and device information, study documents

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