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

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: SLx-4090; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562575

SLx-4090-07-03

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

SLx-4090

Treatment:

Drug: SLx-4090

2

Placebo Comparator group

Description:

Matching Placebo Dose

Treatment:

Drug: Placebo