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

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Raynaud's Disease

Treatments: Drug: Placebo; Drug: SLx-2101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528242

SLx-2101-07-04

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

SLx-2101

Treatment:

Drug: SLx-2101

2

Placebo Comparator group

Description:

Matching Placebo Dose

Treatment:

Drug: Placebo