Safety, Tolerability, and Pharmacodynamic Profile of Oral... | NCT00528242

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

NCT00528242

Sponsor

Response Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

17Actual

Phase

Phase 2

Conditions

Raynaud's Disease

Interventions

SLx-2101
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official 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.

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Sep 11, 2007

First Submission Date that Met QC Criteria

Sep 11, 2007

First Posted Date

Sep 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 9, 2014

Certification/Extension First Submitted that Passed QC Review

Dec 9, 2014

Certification/Extension First Posted Date

Dec 31, 2014Estimated

Last Update Submitted Date

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SLx-2101	Drug: SLx-2101
2	Placebo Comparator	Matching Placebo Dose	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SLx-2101	Drug		1
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M Baumaker, MD	University des Saarlandes	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University des Saarlandes		Homburg			Germany

Condition Browse Module

MeSH Terms

ID	Term
D011928	Raynaud Disease

Ancestor Terms

ID	Term
D000090122	Livedoid Vasculopathy
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided