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

Arm | Intervention/treatment |
---|---|
Experimental: 1
SLx-2101
|
Drug: SLx-2101 |
Placebo Comparator: 2
Matching Placebo Dose
|
Drug: Placebo |
- Raynaud's condition scores after 14 days of SLx-2101 [ Time Frame: 14 days ]
- Safety and tolerability [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Germany | |
University des Saarlandes | |
Homburg, Germany |
Study Director: | M Baumaker, MD | University des Saarlandes |
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 |