NCT00562575

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 18, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

November 20, 2007

Last Update Submit

November 14, 2023

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Serum triglycerides

    14 days

Secondary Outcomes (1)

  • Adverse events and vital signs

    14 days

Study Arms (2)

1

EXPERIMENTAL

SLx-4090

Drug: SLx-4090

2

PLACEBO COMPARATOR

Matching Placebo Dose

Drug: Placebo

Interventions

SLx-4090DRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects with high triglyceride levels
  • Male or female subjects between age 18 and 65 years, inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FOCUS Clinical Drug Development GmbH

Neuss, D-41460, Germany

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

6-(4'-trifluoromethyl-6-methoxybiphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Grit Anderson, MD

    FOCUS clinical Drug Development GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 22, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 18, 2023

Record last verified: 2023-04

Locations

DE(1)