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

This study has been completed.
Sponsor:
Information provided by:
Surface Logix
ClinicalTrials.gov Identifier:
NCT00562575
First received: November 20, 2007
Last updated: December 17, 2008
Last verified: October 2007
  Purpose

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
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 Surface Logix:

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
SLx-4090 vs. placebo
Drug: SLx-4090

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00562575

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

No publications provided

Responsible Party: Warwick Tong, MB, ChB, Surface Logix, Inc.
ClinicalTrials.gov Identifier: NCT00562575     History of Changes
Other Study ID Numbers: SLx-4090-07-03
Study First Received: November 20, 2007
Last Updated: December 17, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 23, 2014