Chronic Hepatitis BPhase 1NCT03662568
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
A Phase 1 study testing GLS4, RTV and ETV 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 Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GLS4, RTV and ETV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2018to 10 Jun 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
- Be able to complete the study according to the trail protocol
- Subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures
- Male subjects and must be 18 to 45 years of age inclusive
- Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive
- Physical examination and vital signs without clinically significant abnormalities.
Who cannot join
- Use of >5 cigarettes per day during the past 3 months
- Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies)
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
- Donation or loss of blood over 450 mL within 3 months prior to screening
- 12-lead ECG with clinically significant
- Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
- Subjects deemed unsuitable by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects
Read the detailed description
This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects.
Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.
- Conditions
- Chronic Hepatitis B
- Being tested
- GLS4, RTV, ETV, TDF
- 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
Also called Morphothiadine Mesilate Capsules
Administered GLS4 120 mg orally three times daily in fed state
RTVDrug
Also called Ritonavir tablet
Administered RTV 100 mg orally three times daily in fed state
ETVDrug
Also called Entecavir table
Administered orally ETV 0.5 mg once daily in fasted state
TDFDrug
Also called Tenofovir Disoproxil Fumarate table
Administered TDF 300 mg orally once daily in fasted state
| Study group | Role | What they receive |
|---|---|---|
| Part A:Group A | Experimental | Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. Receives: Drug: GLS4; Drug: RTV; Drug: ETV |
| Part A:Group B | Experimental | Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. Receives: Drug: GLS4; Drug: RTV; Drug: ETV |
| Part B:Group C | Experimental | Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. Receives: Drug: GLS4; Drug: RTV; Drug: TDF |
| Part B:Group D | Experimental | Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. Receives: Drug: GLS4; Drug: RTV; Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of study drugs
Measured: Day 1-2 and Day 21-23
AUC
Area under the plasma concentration-time curve of study drugs
Measured: Day 1-2 and Day 21-23
Tmax
Time to maximum concentration of study drugs
Measured: Day 1-2 and Day 21-23
T1/2
Terminal half-life of study drugs
Measured: Day 1-2 and Day 21-23
Adverse events
To assess the safety and tolerability after dosing
Measured: Baseline to day 23
Secondary outcomes (3)
CL/F
Apparent clearance of study drugs
Measured: Day 1-2 and Day 21-23
Vz/F
Apparent volume of distribution of study drugs
Measured: Day 1-2 and Day 21-23
Cmin
Minimum plasma concentration of study drugs
Measured: Day 1-2 and Day 21-23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start26 Jun 2018
- Primary completion31 Jul 2018
- Study completion10 Jun 2019
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT03662568
- Sponsor's protocol ID
- PCD-DGLS4-18-001
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03662568
- Acronym / sponsor ID
- PCD-DGLS4-18-001
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 7 Sep 2018 (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 Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects
Detailed description
This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects.
Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A:Group A | Experimental | Drug: GLS4, Drug: RTV, Drug: ETVSubjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. |
| Part A:Group B | Experimental | Drug: GLS4, Drug: RTV, Drug: ETVSubjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. |
| Part B:Group C | Experimental | Drug: GLS4, Drug: RTV, Drug: TDFSubjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. |
| Part B:Group D | Experimental | Drug: GLS4, Drug: RTV, Drug: TDFSubjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
- Be able to complete the study according to the trail protocol
- Subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures
- Male subjects and must be 18 to 45 years of age inclusive
- Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive
Key exclusion criteria (7 listed)
- Use of >5 cigarettes per day during the past 3 months
- Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies)
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
- Donation or loss of blood over 450 mL within 3 months prior to screening
- 12-lead ECG with clinically significant
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 |
|---|---|---|
| GLS4Also: Morphothiadine Mesilate CapsulesAdministered GLS4 120 mg orally three times daily in fed state | Drug | Part A:Group A, Part A:Group B, Part B:Group C, Part B:Group D |
| RTVAlso: Ritonavir tabletAdministered RTV 100 mg orally three times daily in fed state | Drug | Part A:Group A, Part A:Group B, Part B:Group C, Part B:Group D |
| ETVAlso: Entecavir tableAdministered orally ETV 0.5 mg once daily in fasted state | Drug | Part A:Group A, Part A:Group B |
| TDFAlso: Tenofovir Disoproxil Fumarate tableAdministered TDF 300 mg orally once daily in fasted state | Drug | Part B:Group C, Part B:Group D |
Primary outcome
Cmax
Time frame: Day 1-2 and Day 21-23
Maximum plasma concentration of study drugs
AUC
Time frame: Day 1-2 and Day 21-23
Area under the plasma concentration-time curve of study drugs
Tmax
Time frame: Day 1-2 and Day 21-23
Time to maximum concentration of study drugs
T1/2
Time frame: Day 1-2 and Day 21-23
Terminal half-life of study drugs
Adverse events
Time frame: Baseline to day 23
To assess the safety and tolerability after dosing
3 secondary outcomes
CL/F
Time frame: Day 1-2 and Day 21-23
Vz/F
Time frame: Day 1-2 and Day 21-23
Cmin
Time frame: Day 1-2 and Day 21-23
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 9 Oct 2019.
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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 GLS4, RTV and ETV 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 6 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 9 Oct 2019. 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: Day 1-2 and Day 21-23). The study lists 5 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 9 Oct 2019.