Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine

Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects

The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine after multiple dose in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: HS-10234; Drug: Emtricitabine

Detailed Description

The study includes two parts. Part 1 is to evaluate the impact of Emtricitabine on HS-10234. Part 2 is to evaluate the impact of HS-10234 on Emtricitabine.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Voluntarily sign an informed consent before any activities related to this trial and understand the procedures and methods of this trial;
2. Aged between 18 and 55 years old (including cutoff value), both male and female;
3. Male body weight ≥50.0kg, female body weight ≥45.0kg, body mass index (BMI) is 19~26 kg/m2 (including both ends);
4. Those who signed the informed consent form and had no birth plan within 3 months after the last dose and agreed to take effective contraceptive measures.

Exclusion Criteria:

1. People who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that can interfere with the test results, Or have a stomach problem or have a history of stomach problems;
2. People who have drugs (penicillin or cephalosporin drugs), food, or have a history of allergy to test drugs or similar drugs;
3. If the subject have a history of surgery within the 4 weeks prior to the trial or plan to undergo surgery during the study period or have surgery that affected the absorption, distribution, metabolism, and excretion of drugs;
4. Those who took any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before taking the study drug, or those who were within 5 half-lives of the drug at the time of screening; those who plan to take non-study drugs or health products during the trial;
5. Those who participated in any drug clinical trial and used any trial drug within 3 months before administration (subject to the informed consent);
6. Participate in blood donation within 3 months before administration and the amount of blood donation >200 mL, or have received blood transfusion;
7. Unable or unwilling to follow the lifestyle guidelines required in the plan;
8. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial;
9. Alcoholics or frequent drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or before administration Alcohol screening positive;
10. People who have a history of drug abuse, drug dependence, or a positive drug screen before administration;
11. Screening/baseline visit to alanine aminotransferase and/or aspartate aminotransferase and/or alkaline phosphatase and/or total bilirubin exceeds 1.2 times the upper limit of normal;
12. Abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm) or physical examination, electrocardiogram, laboratory examination, imaging examination, etc. Abnormality has clinical significance (subject to the judgment of the clinical research doctor);
13. The QT interval is prolonged during screening (calculated using Bazett's method, male>450 msec, female>460 msec);
14. Hepatitis B surface antigen, hepatitis C antibody, syphilis serotonin, HIV antibody test positive;
15. Women during pregnancy or lactation;
16. Subjects may not be able to complete the study for other reasons or the investigator believes that they should not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: single arm for each part: two arms; PART1:In the first period, HS-10234 will be administered at 25 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days. PART2:In the first period, Emtricitabine will be administered at 200 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days.

Drug: HS-10234; HS-10234; Drug: Emtricitabine; Emtricitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine	Cmax	0 - 24 hour on 7th day
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine	AUC0-tau	0 - 24 hour on 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells.	Concentration	0 - 24 hour on 7th day
Incidence of AEs,	laboratory abnormalities (based on hematology, biochemistry, and urinalysis tests)	0 - 23 day
Incidence of AEs,	body temperature	0 - 23 day
Incidence of AEs,	respiratory rate	0 - 23 day
Incidence of AEs,	blood pressure	0 - 23 day
Incidence of AEs,	pulse rate	0 - 23 day
Incidence of AEs,	Resting 12-lead ECG parameters（ECG QT Interval）	0 - 23 day

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Guoping Yang, Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• Luo Y, Chen W, Yang G, Zou C, Huang J, Kuang Y, Shen K, Zhang B, Yang S, Xiang H, Li Z, Pei Q. Study on Pharmacokinetic Interactions Between HS-10234 and Emtricitabine in Healthy Subjects: An Open-Label, Two-Sequence, Self-Controlled Phase I Trial. Infect Dis Ther. 2022 Feb;11(1):175-186. doi: 10.1007/s40121-021-00555-y. Epub 2021 Oct 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2020
• Primary Completion (ACTUAL): September 24, 2020
• Study Completion (ACTUAL): September 24, 2020

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine
• Other Study ID Numbers: HS-10234-108

Drug and device information, study documents

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