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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
SLx-4090
Placebo
Sponsored by
Kadmon Corporation, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FOCUS Clinical Drug Development GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

SLx-4090

Matching Placebo Dose

Outcomes

Primary Outcome Measures

Serum triglycerides

Secondary Outcome Measures

Adverse events and vital signs

Full Information

First Posted
November 20, 2007
Last Updated
January 26, 2015
Sponsor
Kadmon Corporation, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00562575
Brief Title
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides
Official Title
A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics Profile of SLx-4090 Over 14 Days Dosing in Subjects With High Triglyceride Values
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon Corporation, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SLx-4090
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching Placebo Dose
Intervention Type
Drug
Intervention Name(s)
SLx-4090
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Serum triglycerides
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Adverse events and vital signs
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Anderson, MD
Organizational Affiliation
FOCUS clinical Drug Development GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
FOCUS Clinical Drug Development GmbH
City
Neuss
ZIP/Postal Code
D-41460
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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