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

Response Pharmaceuticals17 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Raynaud's Disease

Interventions

SLx-2101DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University des Saarlandes

Homburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 14 days

Secondary Outcomes

Safety and tolerability

Time frame: 14 days

Data from ClinicalTrials.gov

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