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

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ClinicalTrials.gov Identifier: NCT00528242
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

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

Condition or disease Intervention/treatment Phase
Raynaud's Disease Drug: SLx-2101 Drug: Placebo Phase 2

Detailed Description:
  1. Number and cumulative duration of Raynaud's attacks.
  2. Adverse events and changes in vital signs.
  3. 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
SLx-2101
 Drug: SLx-2101
Placebo Comparator: 2
Matching Placebo Dose
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Raynaud's condition scores after 14 days of SLx-2101 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00528242     History of Changes
Other Study ID Numbers: SLx-2101-07-04
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases