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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00562575
Enrollment
24
Registered
2007-11-22
Start date
2007-05-31
Completion date
2008-02-29
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

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

Interventions

DRUGPlacebo

Sponsors

Response Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Serum triglycerides14 days

Secondary

MeasureTime frame
Adverse events and vital signs14 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026