Healthy ConditionPhase 1/2NCT01905878
Biological Half Life of DLBS1033 in Healthy Volunteers
A Phase 1/2 study testing DLBS1033 in people with Healthy Condition, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Condition
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 1/2
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-55 years old
- Body mass index between 18-25 kg/m2
- Normal physical examination
- Patient still have the ability to undergo examinations and give written informed consent
- Plasmin-antiplasmin complex (PAP complex) level between 0-514 ng/ml
Who cannot join
- Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia
- Creatinin serum more than 1,5 x ULN
- SGOT and SGPT more than 3 x ULN
- Blood pressure ≥ 140/90 mmHg
- Fasting blood glucose > 126 mg/dL
- Alcohol patients
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- Took any medications (including traditional medicine, supplement and vitamin) in 1 week before the study)
- Patient has bleeding history which unclear etiology
- Hemoglobin < 10 g/dL
- Thrombocyte count < 100.000/microliter
- Heavy smoker (Bringman Index > 600)
Trial locations and contacts
1 site in 1 country.
About this study
DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a drug that consists of serin protease enzyme, suspected that the mechanism of action of lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic of this drug. As a pilot study, the aim of this study is to evaluate biological half life of DLBS1033.
- Conditions
- Healthy Condition
- Being tested
- DLBS1033
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1033Drug
| Study group | Role | What they receive |
|---|---|---|
| single dose DLBS1033 | Experimental | Before taking the drug, blood samples will be collected from subject to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take three tablets enteric coated of DLBS1033 in front of investigator. After take the medicine blood sample will be collected on 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. Receives: Drug: DLBS1033 |
| steady state of DLBS1033 | Experimental | On day 1 blood samples will be collected to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take one tablet of DLBS1033 in front of investigator. Study drug packages (that consist of 8 tablets) will dispense to the subjects at day-1 and instructed to take the drug 3 times daily 30 minutes before meals. Subjects also will instructed to record any adverse events and concomitant medication prescribed in diary card. Subjects have to take the drug on 3 days (day 1, 2, and 3). On day 4, blood sample will be collected on 0 minutes, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. Receives: Drug: DLBS1033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial Plasmin-antiplasmin complex (PAP complex)
PAP complex will be measured on 0 minute, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ConditionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was open label-single arm trial, which was done at Pharmacology and Therapeutic Department and Clinical Pathologic Department of Faculty Medicine of University of Indonesia Cipto Mangunkusumo Hospital. The study drug was enteric coated DLBS1033 tablet, which contained 490 mg bioactive protein fraction; and produced by PT Dexa Medica, Tangerang, Indonesia.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dexa Medica Group
- Responsible party
- Principal investigator, Melva Louisa, Universitas Indonesia
- Investigators
- Anggi Gayatri, MD, SpFK, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905878
- Sponsor's protocol ID
- halflifeDLBS1033
- Status last verified
- May 2017
- First submitted
- 11 Jul 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Half Life of DLBS1033 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01905878
- Acronym / sponsor ID
- halflifeDLBS1033
- Conditions
- Healthy Condition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dexa Medica Group
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Jul 2013 (estimated)
- 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.
DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a drug that consists of serin protease enzyme, suspected that the mechanism of action of lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic of this drug. As a pilot study, the aim of this study is to evaluate biological half life of DLBS1033.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was open label-single arm trial, which was done at Pharmacology and Therapeutic Department and Clinical Pathologic Department of Faculty Medicine of University of Indonesia Cipto Mangunkusumo Hospital. The study drug was enteric coated DLBS1033 tablet, which contained 490 mg bioactive protein fraction; and produced by PT Dexa Medica, Tangerang, Indonesia.
| Arm | Type | Receives |
|---|---|---|
| single dose DLBS1033 | Experimental | Drug: DLBS1033Before taking the drug, blood samples will be collected from subject to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take three tablets enteric coated of DLBS1033 in front of investigator. After take the medicine blood sample will be collected on 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. |
| steady state of DLBS1033 | Experimental | Drug: DLBS1033On day 1 blood samples will be collected to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take one tablet of DLBS1033 in front of investigator. Study drug packages (that consist of 8 tablets) will dispense to the subjects at day-1 and instructed to take the drug 3 times daily 30 minutes before meals. Subjects also will instructed to record any adverse events and concomitant medication prescribed in diary card. Subjects have to take the drug on 3 days (day 1, 2, and 3). On day 4, blood sample will be collected on 0 minutes, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- 18-55 years old
- Body mass index between 18-25 kg/m2
- Normal physical examination
- Patient still have the ability to undergo examinations and give written informed consent
Key exclusion criteria (11 listed)
- Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia
- Creatinin serum more than 1,5 x ULN
- SGOT and SGPT more than 3 x ULN
- Blood pressure ≥ 140/90 mmHg
- Fasting blood glucose > 126 mg/dL
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 |
|---|---|---|
| DLBS1033 | Drug | single dose DLBS1033, steady state of DLBS1033 |
Primary outcome
Serial Plasmin-antiplasmin complex (PAP complex)
Time frame: 3 days
PAP complex will be measured on 0 minute, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour
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 12 May 2017.
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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.
Anggi Gayatri, MD, SpFK principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DLBS1033 in people with Healthy Condition, run by Universitas Indonesia at 1 site in Indonesia.
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 11 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 12 May 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 Indonesia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serial Plasmin-antiplasmin complex (PAP complex) (time frame: 3 days). 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 12 May 2017.