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.

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Oshadi D

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel
    • Assaf Harofe Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Oshadi D; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels	24 hours

Collaborators and Investigators

• Sponsor: Oshadi Drug Administration
• Investigators: Principal Investigator: Keren Duanis, MD, Assaf Harofe Medical Center, Israel; Study Director: Hanna Levy, Dr., Oshadi Drug Administration

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Estimate): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: lupus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: OS-DN-P1b-01