Evaluation of Safety and Effects of SLx-4090 After Dosing... | NCT00562575

Studies
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides

NCT00562575

Sponsor

Response Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

24Actual

Phase

Phase 2

Conditions

Hypertriglyceridemia

Interventions

SLx-4090
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

Status Module

Record Verification Date

Apr 2023

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

May 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 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

The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

Detailed Description

Serum triglycerides
Serum lipids and lipoproteins
Safety and tolerability

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SLx-4090	Drug: SLx-4090
2	Placebo Comparator	Matching Placebo Dose	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SLx-4090	Drug		1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum triglycerides		14 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events and vital signs		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects with high triglyceride levels
Male or female subjects between age 18 and 65 years, inclusive

Exclusion Criteria:

History of drug abuse
Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
Blood donation of more than 500ml blood in the previous 3 months
Any confirmed significant allergic reaction against any drug or multiple allergies

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
Grit Anderson, MD	FOCUS clinical Drug Development GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FOCUS Clinical Drug Development GmbH		Neuss		D-41460	Germany

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C559489	6-(4'-trifluoromethyl-6-methoxybiphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided