A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets
Overview
- Phase
- Phase 1
- Intervention
- TQA3810
- Conditions
- Chronic Hepatitis B
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 759
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- •Able to complete the study according to the requirements of the trial protocol;
- •The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix;
- •Male and female subjects aged 18-55 years old (including 18 and 55 years old);
- •The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value);
- •The physical examination and vital signs were normal or abnormal without clinical significance.
Exclusion Criteria
- •Smoking more than 5 cigarettes per day in the 3 months before the study;
- •Allergic constitution (multi-drug and food allergy);
- •A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine);
- •Donation or massive blood loss (\> 400 mL) within 3 months before screening;
- •Taking any drugs that alter liver enzyme activity 28 days before screening;
- •Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening;
- •Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion;
- •Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone, within three months before taking the study drug;
- •A recent major change in diet or exercise habits;
- •Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug;
Arms & Interventions
0.5mg single-dose
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
1.0mg single-dose
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
Food impact group
Sixteen subjects were enrolled and all received the trial drug.
Intervention: TQA3810
0.1mg single-dose
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
0.3mg single-dose
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
Drug interaction group
Sixteen subjects were enrolled and all received the trial drug.
Intervention: TQA3810
0.1mg multiple dosing
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
0.3mg multiple dosing
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
0.5mg multiple dosing
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
0.2mg multiple dosing
Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.
Intervention: TQA3810
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: From the subject signed the informed consent form to 30 days after the last dose
Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.
Secondary Outcomes
- Half-life (t1/2)(Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose)
- Cmax(Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose)
- Tmax(Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose)
- AUC0-t(Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose)
- AUC0-∞(Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose)