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

This study has been completed.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:
First received: November 20, 2007
Last updated: January 26, 2015
Last verified: January 2015
The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

Condition Intervention Phase
Drug: SLx-4090
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Serum triglycerides [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and vital signs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: SLx-4090
Placebo Comparator: 2
Matching Placebo Dose
Drug: Placebo

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00562575

FOCUS Clinical Drug Development GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Kadmon Corporation, LLC
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 
Study First Received: November 20, 2007
Last Updated: January 26, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 26, 2016