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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2011

Last Updated Date

June 20, 2012

Start Date ^ICMJE

April 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01327352 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Influence of Food Regimen on Oshadi D Absorption

Official Title ^ICMJE

A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Lupus Erythematosus, Systemic

Intervention ^ICMJE

Drug: Oshadi D

oral administration

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01327352

Other Study ID Numbers ^ICMJE

OS-DN-P1b-01

Has Data Monitoring Committee

Responsible Party

Oshadi Drug Administration

Study Sponsor ^ICMJE

Oshadi Drug Administration

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Oshadi Drug Administration

Verification Date

June 2012

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

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