Healthy SubjectsPhase 1NCT04477096
Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine
A Phase 1 study testing HS-10234 and Emtricitabine in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine after multiple dose in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HS-10234 and Emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to 24 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign an informed consent before any activities related to this trial and understand the procedures and methods of this trial;
- Aged between 18 and 55 years old (including cutoff value), both male and female;
- Male body weight ≥50.0kg, female body weight ≥45.0kg, body mass index (BMI) is 19~26 kg/m2 (including both ends);
- 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.
Who cannot join
- 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;
- People who have drugs (penicillin or cephalosporin drugs), food, or have a history of allergy to test drugs or similar drugs;
- 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;
- 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;
- Those who participated in any drug clinical trial and used any trial drug within 3 months before administration (subject to the informed consent);
- Participate in blood donation within 3 months before administration and the amount of blood donation >200 mL, or have received blood transfusion;
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- Unable or unwilling to follow the lifestyle guidelines required in the plan;
- Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial;
- 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;
- People who have a history of drug abuse, drug dependence, or a positive drug screen before administration;
- 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;
- 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);
- The QT interval is prolonged during screening (calculated using Bazett's method, male>450 msec, female>460 msec);
- Hepatitis B surface antigen, hepatitis C antibody, syphilis serotonin, HIV antibody test positive;
- Women during pregnancy or lactation;
- Subjects may not be able to complete the study for other reasons or the investigator believes that they should not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- HS-10234, Emtricitabine
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10234Drug
HS-10234
EmtricitabineDrug
Emtricitabine
| Study group | Role | What they receive |
|---|---|---|
| single arm for each part: two arms | Other | 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. Receives: Drug: HS-10234; Drug: Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
Cmax
Measured: 0 - 24 hour on 7th day
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
AUC0-tau
Measured: 0 - 24 hour on 7th day
Secondary outcomes (7)
Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells.
Concentration
Measured: 0 - 24 hour on 7th day
Incidence of AEs,
laboratory abnormalities (based on hematology, biochemistry, and urinalysis tests)
Measured: 0 - 23 day
Incidence of AEs,
body temperature
Measured: 0 - 23 day
Incidence of AEs,
respiratory rate
Measured: 0 - 23 day
Incidence of AEs,
blood pressure
Measured: 0 - 23 day
Incidence of AEs,
pulse rate
Measured: 0 - 23 day
Incidence of AEs,
Resting 12-lead ECG parameters（ECG QT Interval）
Measured: 0 - 23 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 Aug 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477096
- Sponsor's protocol ID
- HS-10234-108
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34727366
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04477096
- Acronym / sponsor ID
- HS-10234-108
- Conditions
- Healthy Subjects
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine after multiple dose in healthy subjects.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm for each part: two arms | Other | Drug: HS-10234, Drug: EmtricitabinePART1: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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign an informed consent before any activities related to this trial and understand the procedures and methods of this trial;
- Aged between 18 and 55 years old (including cutoff value), both male and female;
- Male body weight ≥50.0kg, female body weight ≥45.0kg, body mass index (BMI) is 19~26 kg/m2 (including both ends);
- 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.
Key exclusion criteria (16 listed)
- 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;
- People who have drugs (penicillin or cephalosporin drugs), food, or have a history of allergy to test drugs or similar drugs;
- 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;
- 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;
- Those who participated in any drug clinical trial and used any trial drug within 3 months before administration (subject to the informed consent);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10234HS-10234 | Drug | single arm for each part: two arms |
| EmtricitabineEmtricitabine | Drug | single arm for each part: two arms |
Primary outcome
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
Time frame: 0 - 24 hour on 7th day
Cmax
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
Time frame: 0 - 24 hour on 7th day
AUC0-tau
7 secondary outcomes
Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells.
Time frame: 0 - 24 hour on 7th day
Incidence of AEs,
Time frame: 0 - 23 day
Incidence of AEs,
Time frame: 0 - 23 day
Incidence of AEs,
Time frame: 0 - 23 day
Incidence of AEs,
Time frame: 0 - 23 day
Incidence of AEs,
Time frame: 0 - 23 day
Incidence of AEs,
Time frame: 0 - 23 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 34727366Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoping Yang principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10234 and Emtricitabine in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine (time frame: 0 - 24 hour on 7th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.