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Completed

NCT Number: NCT00528242

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

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

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Key information

Conditions

Raynaud's Disease Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University des Saarlandes

Homburg, Germany

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLx-2101

Drug

Placebo

Drug

Primary outcomes

  1. Raynaud's condition scores after 14 days of SLx-2101

    Time frame: 14 days

Secondary outcomes

  1. Safety and tolerability

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Response Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2007
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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