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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00562575
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: SLx-4090 Drug: Placebo Phase 2

Detailed Description:
  1. Serum triglycerides
  2. Serum lipids and lipoproteins
  3. Safety and tolerability

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
SLx-4090
Drug: SLx-4090
Placebo Comparator: 2
Matching Placebo Dose
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Serum triglycerides [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Adverse events and vital signs [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562575


Locations
Germany
FOCUS Clinical Drug Development GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Kadmon Corporation, LLC
Investigators
Principal Investigator: Grit Anderson, MD FOCUS clinical Drug Development GmbH
More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00562575     History of Changes
Other Study ID Numbers: SLx-4090-07-03
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases