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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00528242

Enrollment

Registered

2007-09-12

Start date

2007-06-30

Completion date

2008-03-31

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud's Disease

Brief 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

Interventions

DRUGSLx-2101

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety and tolerability	14 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026