Evaluation of the Influence of Food Regimen on Oshadi D Absorption

NCT01327352 | Completed

• 1 other identifier: OS-DN-P1b-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 the influence of food on Oshadi D absorption.

Conditions

Lupus Erythematosus, Systemic

Keywords

lupus

Outcome Measures

Primary Outcomes (1)

• DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen

  24 hours

Secondary Outcomes (1)

• Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels

  24 hours

Study Arms (1)

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.

Drug: Oshadi D

Interventions

Oshadi D DRUG

oral administration

Oshadi D

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Assaf Harofe Medical Center,

Zrifin, Israel

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Keren Duanis, MD

  Assaf Harofe Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Hanna Levy, Dr.

  Oshadi Drug Administration

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 1, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

IL (1)