Chronic Hepatitis CPhase 1NCT04201275
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects
A Phase 1 study testing HEC74647PA capsule in people with Chronic Hepatitis C, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- HEC74647PA capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2019to 21 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to complete the study according to the protocol;
- Agree to use protocol defined precautions against pregnancy
- Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
- HCV treatment-naïve adult subjects with GT1-6 HCV infection
- HCV RNA level ≥ 5 log10 IU/mL at screening
- FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis
Who cannot join
- Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- Donated blood or massive blood loss within 3 months before screening (>450 mL）;
- Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
- Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
- Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;
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- Have participated in any clinical trial or taken any study drug within 3 months before dosing;
- Positive test result of HBV,HIV or syphilis;
- Solid organ transplanters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection
The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.
Read the detailed description
All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.
- Conditions
- Chronic Hepatitis C
- Being tested
- HEC74647PA capsule, placebo
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC74647PA capsuleDrug
Capsule administered orally once daily
placeboDrug
HEC74647PA capsule matching placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | up to HEC74647PA capsule 50 mg once daily for 3 days Receives: Drug: HEC74647PA capsule |
| Cohort 2 | Experimental | up to HEC74647PA capsule 100 mg once daily for 3 days Receives: Drug: HEC74647PA capsule |
| Cohort 3 | Experimental | up to HEC74647PA capsule 200 mg once daily for 3 days Receives: Drug: HEC74647PA capsule |
| Cohort 4 | Placebo comparator | up to placebo once daily for 3 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events,laboratory abnormalities and other abnormalities
Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647
Measured: 8 days
Antiviral Activity
Change from baseline in HCV RNA following dose administration of HEC74647
Measured: 8 days
Sequence changes in the NS5A coding region
Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
Measured: 8 days
Cmax
Maximum observed plasma concentration of HEC74647
Measured: 8 days
Tmax
Time of the maximum observed plasma concentration
Measured: 8 days
AUC
Area under the plasma concentration-time curve (AUC)
Measured: 8 days
t1/2
Terminal elimination half-life
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start18 Dec 2019
- Primary completion17 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201275
- Sponsor's protocol ID
- HEC74647-P-02
- Status last verified
- Mar 2020
- First submitted
- 13 Dec 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT04201275
- Acronym / sponsor ID
- HEC74647-P-02
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 17 Dec 2019 (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 goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.
Detailed description
All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HEC74647PA capsuleup to HEC74647PA capsule 50 mg once daily for 3 days |
| Cohort 2 | Experimental | Drug: HEC74647PA capsuleup to HEC74647PA capsule 100 mg once daily for 3 days |
| Cohort 3 | Experimental | Drug: HEC74647PA capsuleup to HEC74647PA capsule 200 mg once daily for 3 days |
| Cohort 4 | Placebo comparator | Drug: placeboup to placebo once daily for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to complete the study according to the protocol;
- Agree to use protocol defined precautions against pregnancy
- Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
- HCV treatment-naïve adult subjects with GT1-6 HCV infection
Key exclusion criteria (9 listed)
- Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- Donated blood or massive blood loss within 3 months before screening (>450 mL）;
- Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
- Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
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 |
|---|---|---|
| HEC74647PA capsuleCapsule administered orally once daily | Drug | Cohort 1, Cohort 2, Cohort 3 |
| placeboHEC74647PA capsule matching placebo administered orally once daily | Drug | Cohort 4 |
Primary outcome
Adverse Events,laboratory abnormalities and other abnormalities
Time frame: 8 days
Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647
Antiviral Activity
Time frame: 8 days
Change from baseline in HCV RNA following dose administration of HEC74647
Sequence changes in the NS5A coding region
Time frame: 8 days
Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
Cmax
Time frame: 8 days
Maximum observed plasma concentration of HEC74647
Tmax
Time frame: 8 days
Time of the maximum observed plasma concentration
AUC
Time frame: 8 days
Area under the plasma concentration-time curve (AUC)
t1/2
Time frame: 8 days
Terminal elimination half-life
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 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Yanhua Ding, Doctor principal investigator
The First Hospital of Jilin 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 HEC74647PA capsule in people with Chronic Hepatitis C, run by Sunshine Lake Pharma 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 7 inclusion and 9 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 19 Mar 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. Some participants in this study may receive a placebo. 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?
Adverse Events,laboratory abnormalities and other abnormalities (time frame: 8 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2020.