Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kadmon Corporation, LLC

ClinicalTrials.gov Identifier:

NCT00528242

First received: September 11, 2007

Last updated: January 26, 2015

Last verified: January 2015

History of Changes

Purpose

To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

Condition	Intervention	Phase
Raynaud's Disease	Drug: SLx-2101 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.

Resource links provided by NLM:

MedlinePlus related topics: Raynaud's Disease

U.S. FDA Resources

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:

Raynaud's condition scores after 14 days of SLx-2101 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]


Enrollment:	17
Study Start Date:	June 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 SLx-2101	Drug: SLx-2101
Placebo Comparator: 2 Matching Placebo Dose	Drug: Placebo

Detailed Description:

Number and cumulative duration of Raynaud's attacks.
Adverse events and changes in vital signs.
SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male and female ages 18 and 65 y.o.
BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).

Exclusion Criteria:

Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528242

Locations


Germany
University des Saarlandes
Homburg, Germany

Sponsors and Collaborators

Kadmon Corporation, LLC

Investigators


Study Director:	M Baumaker, MD	University des Saarlandes

More Information

No publications provided


Responsible Party:	Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:	NCT00528242 History of Changes
Other Study ID Numbers:	SLx-2101-07-04
Study First Received:	September 11, 2007
Last Updated:	January 26, 2015
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:


Raynaud Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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