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Chronic Hepatitis BPhase 1NCT03180333

The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers

A Phase 1 study testing PNA in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a single oral administration of different doses of PNA on the condition of fasting, the… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis B
What is being tested?
PNA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteChina
Study dates
Mar 2012to Aug 2012
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers aged 18 to 45 years old ;
  • Body mass index (BMI) above/equal 19 and below 24 kg/m2;
  • Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;
  • Subjects with no cardiovascular, liver, kidney, digestive tract, nervous and mental and other acute or chronic diseases that may affect the safety and pharmacokinetic of drug;
  • Signed informed consent voluntarily.

Who cannot join

  • Subjects not meet the inclusion criteria;
  • Abnormal clinically significant laboratory results;
  • Abnormal clinically significant electrocardiogram (ECG);
  • A positive hepatitis B surface antigen, hepatitis C or HIV test result;
  • History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes;
  • Addicted to smoking and drinking;
Show all 15Show fewer
  • Drink in 36 hours before post-dosing of study drug;
  • Ingest any foods or beverages which may affect pharmacokinetics;
  • Drug abuse,a history of poisoning;
  • Subjects who had received other medications within 2 weeks prior to the first administration of Investigational Product，and the original and main metabolites were not completely eliminated ;
  • Subjects who participated in any other clinical trials within 3 months prior to the first administration of Investigational Product;
  • Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded;
  • Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the first administration of Investigational Product;
  • Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions;
  • Subjects in the opinion of the investigator, could not participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu

Other trials in China

About this study

Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a single oral administration of different doses of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are estimated;3.By measuring the changing drug concentration in the plasma of PNA after a multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters of multiple-dose are estimated, and a basis for dosage regimens of the clinical research phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the changes of concentration of PNA in plasma after high-fat and high-calorie food.

Read the detailed description

The study is divided into three parts:

  1. The tolerance test of randomized，double-blind, placebo-controlled multiple-dose oral administrations.2 dosage groups are set up.Each group contains 8 subjects,evenly composed of men and women.The beginning dosage of the study is 160mg/L.Subjects who have successfully completed tests of the beginning dosage group and passed the safety assessment will enter the test of next dosage group(320mg/L) according to the same method.
  2. Pharmacokinetic tests(single/multiple dose) .(1)Single dosing pharmacokinetic tests.36 eligible healthy subjects are selected. Each group has 12 people, evenly composed of men and women. After taking 80mg/160mg/320mg of PNA orally in fasting state, blood and urine samples are taken to be tested and analyzed, in order to study the pharmacokinetic characteristics of single-dose administrations.(2)Multiple dosing pharmacokinetic tests.In the single-dose administration trial, respectively choose 10 subjects (evenly composed of men and women) in middle and high-dose group (160mg qd、320mg qd).After the single-dose administration,inspecte the pharmacokinetic characteristics with 6-day continuous administration. Blood samples are taken to test the trough drug concentration of pre-dose in the morning of the 3rd, 4th, 5th day after administration, and the 6th morning before and after the administration, to study the steady state concentration and the fluctuation coefficient of the trough to peak drug concentration after multiple-dose, and to find out whether there exists the effect of drug storage and / or induction of drug enzyme.
  3. The effect of diet.Choose 12 qualified healthy subjects (normally evenly composed of men and women), a randomized two-way cross-over design is used, respectively orally take 160 mg of PNA before and after meal, and to study the effect of diet on pharmacokinetic via blood collection.
Being tested
PNA, PNA placebo
Keywords
Chronic Hepatitis B
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.

  • PNADrug

    Also called Metacavir Enteric-coated Capsules

  • PNA placeboDrug

    Also called Metacavir Enteric-coated Capsules placebo

Study groups in NCT03180333
Study groupRoleWhat they receive
PNA 1ExperimentalMultiple dosing tolerance test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 7 days;
Receives: Drug: PNA
PNA placeboPlacebo comparatorMultiple dosing tolerance test:Metacavir Enteric-coated Capsules placebo 160mg/320mg,once a day,continuous administration for 7 days
Receives: Drug: PNA placebo
PNA 2ExperimentalSingle dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 80mg/160mg/320mg,single-dose;
Receives: Drug: PNA
PNA 3ExperimentalMultiple dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 6 days;
Receives: Drug: PNA
PNA 4ExperimentalThe effect of diet:Metacavir Enteric-coated Capsules 160mg,before and after meal.
Receives: Drug: PNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TEAEs

    Frequency of treatment-emergent adverse events

    Measured: day 1 to day 14

Secondary outcomes (3)

  1. AUC

    Area under the plasma concentration versus time curve of PNA

    Measured: day 1 to day 7

  2. Cmax

    Maximum Plasma Concentration of PNA

    Measured: day 1 to day 7

  3. T1/2

    The time required while plasma concentration is reduced by half of PNA

    Measured: day 1 to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study startMar 2012
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180333
Sponsor's protocol ID
PNA-20120309-V1
Status last verified
May 2017
First submitted
31 May 2017
Last updated
8 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PNA in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical 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 5 inclusion and 15 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 8 Jun 2017. 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?

TEAEs (time frame: day 1 to day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180333.

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 8 Jun 2017.

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