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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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

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Detailed Description

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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

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Raynaud's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

SLx-2101

Group Type EXPERIMENTAL

SLx-2101

Intervention Type DRUG

2

Matching Placebo Dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SLx-2101

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No