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

Raynaud's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528242
• Other study ID #: SLx-2101-07-04
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2015
• Source: Response Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Disease

Intervention

Drug:
• SLx-2101

• Placebo

Locations

Country	Name	City	State
Germany	University des Saarlandes	Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Response Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raynaud's condition scores after 14 days of SLx-2101		14 days
Secondary	Safety and tolerability		14 days