HBVPhase 1NCT03239353
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects
A Phase 1 study testing Entecavir in people with HBV, run by Aucta Pharmaceuticals, Inc at 1 site in Australia.
Trial summary
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially: Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) 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
- HBV
- What is being tested?
- Entecavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Oct 2017to 20 Jun 2018
- 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
- Subjects will be considered for enrollment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
- Male or female aged between 18 and 55 years (inclusive). Body weight ≥ 50 kg for males, and ≥45 kg for females and Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive), BMI(kg/m2) = body weight(kg)/{height(m)}2;
- Ability to fully understand the purpose, characteristic, method and the possible adverse effects of the trial, and voluntarily signed Informed Consent obtained before any trial-related procedures are performed;
- Ability to comply with the requirements of this trial protocol, including refrain from strenuous exercise/activity 3 days prior to Day -1 (admission) and for 3 days prior to the Day 8, Day 15 and the final follow-up visit on Day 22through the duration of the study
- Have a creatinine clearance (CLCr) ≥ 80 mL/min;
- Male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and been willing and able to continue contraception for 90 days after their dose of the study treatment;
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- Male subjects must refrain from sperm donation from Day -1 through completion of the study and continuing for at least 90 days from the date of last dose of study drug;
- Subjects must refrain from blood donation from Screening through completion of the study and continuing for at least 30 days from date of last dose of study drug;
- AST, ALT and bilirubin ≤ 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
- Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs), and screening laboratory evaluations (hematology, chemistry, and urinalysis must fall within the normal range of the central laboratory reference ranges unless the results have been determined by the Investigator to have no clinical significance).
Who cannot join
- A subject meeting any of the following criteria will be excluded from the study:
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or renal disease, gastrointestinal tract disease (such as dysphagia, gastrointestinal ulcers), respiratory disease, metabolism, skeletal system diseases or other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
- Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
- There are drug-dependent or drug abuse history, or urine drug abuse screening positive;
- Subject smoked more than 5 cigarettes or other tobacco or nicotine-containing products within 1 month prior to dosing and is unwilling to abstain from smoking for 48 hours prior to check-in (Day -1)ing, for the duration of the confinement period and at each follow-up visit;
- Has used an alcohol consumption of more than 14 units of alcohol per week (1 unit of alcohol is equivalent to 360 mL of beer or 45 mL of spirits with 40 % of alcohol or 150 mL of wine) within 6 months prior to screening or taking products containing alcohol 48 hours prior to IMP administration;
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- Participated in any drug or medical device clinical trial within 3 months prior to screening;
- Pregnant or breastfeeding women or pregnancy testing is positive;
- Have taken any prescription medications, over-the-counter medications, supplements or herbal products within 14 days, or 5 half-lives (whichever is longer), of study drug dosing, with the exception of paracetamol and hormonal contraceptive medications, unless in the opinion of the Investigator and/or Medical Monitor that the substance would not have any material impact on participant safety or the quality of study data;
- Donated blood greater than 400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3 months of screening; Or donated blood greater than 200 ml or significant blood loss equivalent to 200 mL within 1 months prior to screening;
- Has infectious diseases within four weeks at screening (in the opinion of the investigator would pose a risk for participation in this study), severe trauma, or a history of major surgery within 3 months;
- Cannot tolerate venepuncture or cannulation;
- Consumption of grapefruit, grapefruit juice, cranberries, or products containing Seville oranges (fruit juices, marmalade, jam, etc) within 7 days prior to study drug dosing; consumption of caffeine-containing products within 48 hours of study drug dosing;
- Have been vaccinated within 90 days of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine ≤ 14 days prior to dosing.
- Have severe multiple allergies and / or severe allergies (including latex / heparin allergy) history, or has hypersensitivity or significant intolerance to prescription drugs or over-the-counter drugs or food;
- Subjects who, in the opinion of the Investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: A Phase 1, Randomized, Partially-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Entecavir Extended Release (XR) in Healthy Subjects
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially:
Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects.
Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy subjects.
- Conditions
- HBV
- Being tested
- Entecavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called placebo
Study drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw.
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg ETV XR tablet | Active comparator | Not described Receives: Drug: Entecavir |
| 3 mg ETV XR tablet | Active comparator | Not described Receives: Drug: Entecavir |
| 6 mg ETV XR tablet | Active comparator | Not described Receives: Drug: Entecavir |
| Placebo-to-match 1.5 mg ETV XR tablet | Placebo comparator | Not described Receives: Drug: Entecavir |
| 0.5 mg ETV IR tablet | Other | Not described Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects.
Peak Plasma Concentration(Cmax)
Measured: 22 days
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Area under the plasma concentration versus time curve (AUC)
Measured: 22 days
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
peak time (Tmax)
Measured: 22 days
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Relative bioavailability (Frelative)
Measured: 22 days
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
half life (t1/2)
Measured: 22 days
Secondary outcomes (5)
To assess ETV XR tablet in healthy subjects.
adverse events
Measured: 22 days
To assess ETV XR tablet in healthy subjects.
laboratory abnormalities
Measured: 22 day
To assess ETV XR tablet in healthy subjects.
vital signs
Measured: 22 days
To assess ETV XR tablet in healthy subjects.
12-lead electrocardiograms (ECGs)
Measured: 22 days
To evaluate the dose linearity of ETV XR tablet
1.5mg, 3mg and 6mg PK linearity
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start20 Oct 2017
- Primary completion29 May 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aucta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239353
- Sponsor's protocol ID
- UAP008C001
- Status last verified
- Jun 2018
- First submitted
- 27 Jul 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Partially-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Entecavir Extended Release (XR) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03239353
- Acronym / sponsor ID
- UAP008C001
- Conditions
- HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aucta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 4 Aug 2017 (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.
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially:
Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects.
Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg ETV XR tablet | Active comparator | Drug: Entecavir |
| 3 mg ETV XR tablet | Active comparator | Drug: Entecavir |
| 6 mg ETV XR tablet | Active comparator | Drug: Entecavir |
| Placebo-to-match 1.5 mg ETV XR tablet | Placebo comparator | Drug: Entecavir |
| 0.5 mg ETV IR tablet | Other | Drug: Entecavir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will be considered for enrollment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
- Male or female aged between 18 and 55 years (inclusive). Body weight ≥ 50 kg for males, and ≥45 kg for females and Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive), BMI(kg/m2) = body weight(kg)/{height(m)}2;
- Ability to fully understand the purpose, characteristic, method and the possible adverse effects of the trial, and voluntarily signed Informed Consent obtained before any trial-related procedures are performed;
- Ability to comply with the requirements of this trial protocol, including refrain from strenuous exercise/activity 3 days prior to Day -1 (admission) and for 3 days prior to the Day 8, Day 15 and the final follow-up visit on Day 22through the duration of the study
- Have a creatinine clearance (CLCr) ≥ 80 mL/min;
Key exclusion criteria (16 listed)
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or renal disease, gastrointestinal tract disease (such as dysphagia, gastrointestinal ulcers), respiratory disease, metabolism, skeletal system diseases or other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
- Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
- There are drug-dependent or drug abuse history, or urine drug abuse screening positive;
- Subject smoked more than 5 cigarettes or other tobacco or nicotine-containing products within 1 month prior to dosing and is unwilling to abstain from smoking for 48 hours prior to check-in (Day -1)ing, for the duration of the confinement period and at each follow-up visit;
- Has used an alcohol consumption of more than 14 units of alcohol per week (1 unit of alcohol is equivalent to 360 mL of beer or 45 mL of spirits with 40 % of alcohol or 150 mL of wine) within 6 months prior to screening or taking products containing alcohol 48 hours prior to IMP administration;
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 |
|---|---|---|
| EntecavirAlso: placeboStudy drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw. | Drug | 0.5 mg ETV IR tablet, 1.5 mg ETV XR tablet, 3 mg ETV XR tablet, 6 mg ETV XR tablet, Placebo-to-match 1.5 mg ETV XR tablet |
Primary outcome
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects.
Time frame: 22 days
Peak Plasma Concentration(Cmax)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Time frame: 22 days
Area under the plasma concentration versus time curve (AUC)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Time frame: 22 days
peak time (Tmax)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Time frame: 22 days
Relative bioavailability (Frelative)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
Time frame: 22 days
half life (t1/2)
5 secondary outcomes
To assess ETV XR tablet in healthy subjects.
Time frame: 22 days
To assess ETV XR tablet in healthy subjects.
Time frame: 22 day
To assess ETV XR tablet in healthy subjects.
Time frame: 22 days
To assess ETV XR tablet in healthy subjects.
Time frame: 22 days
To evaluate the dose linearity of ETV XR tablet
Time frame: 60 days
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 27 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for HBV
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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 Entecavir in people with HBV, run by Aucta Pharmaceuticals, Inc at 1 site in Australia.
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 10 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 27 Jun 2018. 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 Australia. 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?
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects. (time frame: 22 days). 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 27 Jun 2018.