Chronic Hepatitis BPhase 1NCT04551261
GLS4/RTV and TAF Drug-drug Interaction
A Phase 1 study testing GLS4, RTV and TAF in people with Chronic Hepatitis B, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GLS4, RTV and TAF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2021to 12 Mar 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
- Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
- Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.
Who cannot join
- In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
- Allergic constitution (multiple drug and food allergies);
- A history of alcoholism;
- Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
- Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
- P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
- Female subjects are lactating or have positive blood pregnancy results during the screening period;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
Read the detailed description
This is a 2-part study with each part is an open-label study in healthy adult subjects.
Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.
- Conditions
- Chronic Hepatitis B
- Being tested
- GLS4, RTV, TAF
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS4Drug
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
RTVDrug
Also called ritonavir
- It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection;
- It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
TAFDrug
Also called tenofovir alafenamide
It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15. Receives: Drug: GLS4; Drug: RTV; Drug: TAF |
| Part B | Experimental | Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15. Receives: Drug: GLS4; Drug: RTV; Drug: TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: predose to 96 hour after dosing
AUC
area under the plasma concentration-time curve (AUC)
Measured: predose to 96 hour after dosing
Adverse event
To assess the safety and tolerability of therapy.
Measured: Baseline to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Jan 2021
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551261
- Sponsor's protocol ID
- PCD-DGLS4-20-001
- Status last verified
- May 2021
- First submitted
- 8 Sep 2020
- Last updated
- 26 May 2022
- Results posted
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04551261
- Acronym / sponsor ID
- PCD-DGLS4-20-001
- Conditions
- Chronic Hepatitis B
- 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
- 10 Jan 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 16 Sep 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 purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
Detailed description
This is a 2-part study with each part is an open-label study in healthy adult subjects.
Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: GLS4, Drug: RTV, Drug: TAFSubjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15. |
| Part B | Experimental | Drug: GLS4, Drug: RTV, Drug: TAFSubjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
- Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
- Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.
Key exclusion criteria (7 listed)
- In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
- Allergic constitution (multiple drug and food allergies);
- A history of alcoholism;
- Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
- Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before 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 |
|---|---|---|
| GLS4It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule. | Drug | Part A, Part B |
| RTVAlso: ritonavir1. It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; 2. It is a CYP3A inhibitor combined with other drug to increase the exposure in human. | Drug | Part A, Part B |
| TAFAlso: tenofovir alafenamideIt is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. | Drug | Part A, Part B |
Primary outcome
Cmax
Time frame: predose to 96 hour after dosing
maximum observed plasma concentration
AUC
Time frame: predose to 96 hour after dosing
area under the plasma concentration-time curve (AUC)
Adverse event
Time frame: Baseline to day 22
To assess the safety and tolerability of therapy.
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 26 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 GLS4, RTV and TAF in people with Chronic Hepatitis B, 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 3 inclusion and 7 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 26 May 2022. 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?
Cmax (time frame: predose to 96 hour after dosing). The study lists 3 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 26 May 2022.