Chronic Hepatitis bPhase 1NCT04277897
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
A Phase 1 study testing Hepenofovir Fumarate Tablets Single Dose and Hepenofovir Fumarate Tablets Dose4 in people with Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd..
Trial summary
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Hepenofovir Fumarate Tablets Single Dose and Hepenofovir Fumarate Tablets Dose4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2020to 30 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
- Able to understand the nature of the study, comply with the protocol, and provide informed consent.
- Subjects willing to adhere to protocol requirements and to finish the study.
- Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration.
- Subjects aged between 18 and 55 years (both inclusive).
- Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
Who cannot join
- History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug).
- Hypersensitivity to different kinds of drugs and food.
- Presence of significant alcoholism or drug abuse.
- Volunteer who have donated blood or lose blood(>450mL)within past 90 days prior to the first dose of the study drug.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study.
- Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study.
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- Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study.
- Any treatment which could bring about induction or inhibition of CYP3A4.
- Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Difficulty in swallowing or other gastrointestinal disease or disorder.
- Presence of an abnormal electrocardiogram (ECG), which was clinically significant.
- Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study.
- Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant.
- Subjects who, in the opinion of the Investigator, should not participate in the study.
About this study
Official title: A Phase Ia Single-center,Randomized,Double-blind,Placebo-controled Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
Read the detailed description
It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.
- Conditions
- Chronic Hepatitis b
- Being tested
- Hepenofovir Fumarate Tablets Single Dose, Placebo, Hepenofovir Fumarate Tablets Dose4
- 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.
Hepenofovir Fumarate Tablets Single DoseDrug
Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).
PlaceboDrug
Placebo to match Hepenofovir Fumarate Tablets
Hepenofovir Fumarate Tablets Dose4Drug
Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition.
| Study group | Role | What they receive |
|---|---|---|
| Drug SAD Cohorts | Experimental | Hepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration. Receives: Drug: Hepenofovir Fumarate Tablets Single Dose |
| Placebo SAD Cohorts | Placebo comparator | Matching placebo, orally, once daily in one single administration. Receives: Drug: Placebo |
| Drug MAD Group | Experimental | Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days. Receives: Drug: Hepenofovir Fumarate Tablets Single Dose |
| Placebo MAD Group | Placebo comparator | Matching placebo, orally, once daily for 7 days. Receives: Drug: Placebo |
| Food-influnced Group | Experimental | Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition. Receives: Drug: Hepenofovir Fumarate Tablets Dose4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by adverse events
Measured: Up to 6 Days in SAD Cohorts
Safety measured by adverse events
Measured: Up to 12 Days in MAD Group
Safety measured by adverse events
Measured: Up to 13 Days in Food-influence Group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start15 Mar 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
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.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277897
- Sponsor's protocol ID
- XAXT-2019-001
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Single-center,Randomized,Double-blind,Placebo-controled Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04277897
- Acronym / sponsor ID
- XAXT-2019-001
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.University, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 20 Feb 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.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
Detailed description
It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Drug SAD Cohorts | Experimental | Drug: Hepenofovir Fumarate Tablets Single DoseHepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration. |
| Placebo SAD Cohorts | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily in one single administration. |
| Drug MAD Group | Experimental | Drug: Hepenofovir Fumarate Tablets Single DoseHepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days. |
| Placebo MAD Group | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 7 days. |
| Food-influnced Group | Experimental | Drug: Hepenofovir Fumarate Tablets Dose4Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand the nature of the study, comply with the protocol, and provide informed consent.
- Subjects willing to adhere to protocol requirements and to finish the study.
- Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration.
- Subjects aged between 18 and 55 years (both inclusive).
- Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale.
Key exclusion criteria (14 listed)
- History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug).
- Hypersensitivity to different kinds of drugs and food.
- Presence of significant alcoholism or drug abuse.
- Volunteer who have donated blood or lose blood(>450mL)within past 90 days prior to the first dose of the study drug.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study.
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 |
|---|---|---|
| Hepenofovir Fumarate Tablets Single DoseOral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD). | Drug | Drug MAD Group, Drug SAD Cohorts |
| PlaceboPlacebo to match Hepenofovir Fumarate Tablets | Drug | Placebo MAD Group, Placebo SAD Cohorts |
| Hepenofovir Fumarate Tablets Dose4Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition. | Drug | Food-influnced Group |
Primary outcome
Safety measured by adverse events
Time frame: Up to 6 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 12 Days in MAD Group
Safety measured by adverse events
Time frame: Up to 13 Days in Food-influence Group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hepenofovir Fumarate Tablets Single Dose and Hepenofovir Fumarate Tablets Dose4 in people with Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd..
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 14 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Safety measured by adverse events (time frame: Up to 6 Days in SAD Cohorts). 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 20 Feb 2020.