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

Primary Purpose

Raynaud's Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
SLx-2101
Placebo
Sponsored by
Kadmon Corporation, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University des Saarlandes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

SLx-2101

Matching Placebo Dose

Outcomes

Primary Outcome Measures

Raynaud's condition scores after 14 days of SLx-2101

Secondary Outcome Measures

Safety and tolerability

Full Information

First Posted
September 11, 2007
Last Updated
January 26, 2015
Sponsor
Kadmon Corporation, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00528242
Brief Title
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon Corporation, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SLx-2101
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching Placebo Dose
Intervention Type
Drug
Intervention Name(s)
SLx-2101
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Raynaud's condition scores after 14 days of SLx-2101
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Baumaker, MD
Organizational Affiliation
University des Saarlandes
Official's Role
Study Director
Facility Information:
Facility Name
University des Saarlandes
City
Homburg
Country
Germany

12. IPD Sharing Statement

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

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