Trials / Completed
CompletedNCT00528242
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Response Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SLx-2101 | |
| DRUG | Placebo |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2007-09-12
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00528242. Inclusion in this directory is not an endorsement.