Clinical Trial: Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
Detailed Summary:
- 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
Sponsor: Kadmon Corporation, LLC
Current Primary Outcome: Raynaud's condition scores after 14 days of SLx-2101 [ Time Frame: 14 days ]
Original Primary Outcome:
Current Secondary Outcome: Safety and tolerability [ Time Frame: 14 days ]
Original Secondary Outcome:
Information By: Kadmon Corporation, LLC
Dates:
Date Received: September 11, 2007
Date Started: June 2007
Date Completion:
Last Updated: January 26, 2015
Last Verified: January 2015
