This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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 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
Hypertriglyceridemia Drug: SLx-4090 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Kadmon Corporation, LLC:

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

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

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   (Adult)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT00562575     History of Changes
Other Study ID Numbers: SLx-4090-07-03
Study First Received: November 20, 2007
Last Updated: January 26, 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on July 19, 2017