Evaluation of the Influence of Food Regimen on Oshadi D Absorption

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327352
• Other study ID #: OS-DN-P1b-01
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: June 20, 2012
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Oshadi D
oral administration

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center,	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen		24 hours	No
Secondary	Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels		24 hours	No