Lupus Erythematosus, SystemicNCT01327352
Evaluation of the Influence of Food Regimen on Oshadi D Absorption
A study testing Oshadi D in people with Lupus Erythematosus, Systemic, run by Oshadi Drug Administration at 1 site in Israel.
Trial summary
The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Oshadi D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Oct 2011
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Male/female 21 years old and up.
- Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
- Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Who cannot join
- Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- Subject with positive HIV serology or positive HBsAg at screening.
- History or evidence of any active liver disease.
- Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- Inability to give written informed consent
- History of alcohol or drug abuse within 6 months of screening.
Show all 13Show fewer
- Subject who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
- Mental disorders.
- Subject with poor venous access
- Significant swallowing disorders
- Digestive disorders;
- Small bowel surgery;
- Mall absorption disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption
The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Oshadi D
- Keywords
- lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi DDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Oshadi D | Experimental | 2 dose levels of Oshadi D in 2 food regimen will be administered as following:
* Subjects will receive placebo on the morning of day 1 during fast. Late breakfast will be provided 4 hours following placebo administration.
* On day 8 a single dose of 180mg Oshadi D will be administrated during fast. Late breakfast will be provided 4 hours following drug administration
* On day 16 subjects will be administered with 360mg of Oshadi D during fast. Late breakfast will be provided 4 hours following drug administration.
* On day 24, 180mg of Oshadi D will be administrated immediately after breakfast.
* On day 32, subject will be administered with 360mg of Oshadi immediately after breakfast. Receives: Drug: Oshadi D |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen
Measured: 24 hours
Secondary outcomes (1)
Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keren Duanis, MD, Principal investigator, Assaf Harofe Medical Center, IsraelHanna Levy, Dr., Study director, Oshadi Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327352
- Sponsor's protocol ID
- OS-DN-P1b-01
- Status last verified
- Jun 2012
- First submitted
- 29 Mar 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption
- ClinicalTrials.gov ID
- NCT01327352
- Acronym / sponsor ID
- OS-DN-P1b-01
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- lupus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Apr 2011 (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.
The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oshadi D | Experimental | Drug: Oshadi D2 dose levels of Oshadi D in 2 food regimen will be administered as following: * Subjects will receive placebo on the morning of day 1 during fast. Late breakfast will be provided 4 hours following placebo administration. * On day 8 a single dose of 180mg Oshadi D will be administrated during fast. Late breakfast will be provided 4 hours following drug administration * On day 16 subjects will be administered with 360mg of Oshadi D during fast. Late breakfast will be provided 4 hours following drug administration. * On day 24, 180mg of Oshadi D will be administrated immediately after breakfast. * On day 32, subject will be administered with 360mg of Oshadi immediately after breakfast. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Male/female 21 years old and up.
- Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
- Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Key exclusion criteria (13 listed)
- Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- Subject with positive HIV serology or positive HBsAg at screening.
- History or evidence of any active liver disease.
- Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- Inability to give written informed consent
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 |
|---|---|---|
| Oshadi Doral administration | Drug | Oshadi D |
Primary outcome
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen
Time frame: 24 hours
1 secondary outcome
Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels
Time frame: 24 hours
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 21 Jun 2012.
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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.
Keren Duanis, MD principal investigator
Assaf Harofe Medical Center, Israel
Hanna Levy, Dr. study director
Oshadi Drug Administration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oshadi D in people with Lupus Erythematosus, Systemic, run by Oshadi Drug Administration at 1 site in Israel.
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 3 inclusion and 13 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 21 Jun 2012. 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 Israel. 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.
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?
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen (time frame: 24 hours). 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 21 Jun 2012.