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

November 14, 2023 updated by: Response Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, D-41460
        • FOCUS Clinical Drug Development GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Matching Placebo Dose
Drug: Placebo
Experimental: 1
SLx-4090
Drug: SLx-4090

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum triglycerides
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events and vital signs
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Response Pharmaceuticals

Investigators

  • Principal Investigator: Grit Anderson, MD, FOCUS Clinical Drug Development GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimated)

November 22, 2007

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLx-4090-07-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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