Evaluation of the Influence of Food Regimen on Oshadi D Absorption

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration
ClinicalTrials.gov Identifier:
NCT01327352
First received: March 29, 2011
Last updated: June 20, 2012
Last verified: June 2012

March 29, 2011
June 20, 2012
April 2011
August 2011   (final data collection date for primary outcome measure)
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01327352 on ClinicalTrials.gov Archive Site
Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Influence of Food Regimen on Oshadi D Absorption
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Lupus Erythematosus, Systemic
Drug: Oshadi D
oral administration
Experimental: Oshadi D

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.
Intervention: Drug: Oshadi D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
October 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01327352
OS-DN-P1b-01
No
Oshadi Drug Administration
Oshadi Drug Administration
Not Provided
Principal Investigator: Keren Duanis, MD Assaf Harofe Medical Center, Israel
Study Director: Hanna Levy, Dr. Oshadi Drug Administration
Oshadi Drug Administration
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP