Evaluation of the Influence of Food Regimen on Oshadi D Absorption - Full Text View

Purpose

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.

Condition	Intervention
Lupus Erythematosus, Systemic	Drug: Oshadi D

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption

Resource links provided by NLM:

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:

DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	April 2011
Study Completion Date:	October 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327352

Locations

Israel
Assaf Harofe Medical Center,
Zrifin, Israel

Sponsors and Collaborators

Oshadi Drug Administration

Investigators

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

More Information

No publications provided

Responsible Party:	Oshadi Drug Administration
ClinicalTrials.gov Identifier:	NCT01327352 History of Changes
Other Study ID Numbers:	OS-DN-P1b-01
Study First Received:	March 29, 2011
Last Updated:	June 20, 2012
Health Authority:	Israel: Ethics Commission

Keywords provided by Oshadi Drug Administration:

lupus

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013