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NCT00562575 Clinical Trial

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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00562575
Other study ID # SLx-4090-07-03
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2007
Est. completion date February 2008

Study information
Verified date April 2023
Source Response Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

Description:

1. Serum triglycerides 2. Serum lipids and lipoproteins 3. Safety and tolerability

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SLx-4090

• Placebo

Locations
Country Name City State
Germany FOCUS Clinical Drug Development GmbH Neuss

Sponsors (1)
Lead Sponsor Collaborator
Response Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum triglycerides 14 days
Secondary Adverse events and vital signs 14 days
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