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

Phase 2

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: SLx-4090; Drug: Placebo

• Registration Number: NCT00562575
• Lead Sponsor: Response Pharmaceuticals

Brief Summary

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

Detailed Description

1. Serum triglycerides

2. Serum lipids and lipoproteins

3. Safety and tolerability

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Disposition First Submitted: 2014-12-09
• Disposition First Submitted QC: 2014-12-09
• Disposition First Posted: 2014-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SLx-4090	SLx-4090
2	Placebo	Matching Placebo Dose

Primary Outcome Measures

Name	Time	Method
Serum triglycerides	14 days

Secondary Outcome Measures

Name	Time	Method
Adverse events and vital signs	14 days

Trial Locations

Locations (1)

FOCUS Clinical Drug Development GmbH; 🇩🇪 Neuss, Germany