NCT01057654

Brief Summary

Lifibrol is a new lipid-lowering drug which lowers cholesterol to an extent in the order of magnitude of the statins. The mechanism of action of this compound is different from the one of statins but remains unknown. The current study will investigate the mechanism of action using stable-isotope turnover methods. The study will be done in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1996

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

January 1, 1996

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1996

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
Last Updated

January 27, 2010

Status Verified

January 1, 2010

Enrollment Period

3 months

First QC Date

January 26, 2010

Last Update Submit

January 26, 2010

Conditions

HypercholesterolemiaHyperlipoproteinemia

Keywords

Cholesterol

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol lowering

    4 weeks

Secondary Outcomes (1)

  • Changes in other lipoprotein concentrations

    4 weeks

Study Arms (2)

Lifibrol

EXPERIMENTAL

Lifibrol (K12.148; 4-(4'-tert. butylphenyl)-1-(4'-carboxyphenoxy)-2-butanol) given as a 600 mg film-coated tablet

Drug: Lifibrol

Pravastatin

ACTIVE COMPARATOR

Pravastatin 40 mg per day

Drug: Pravastatin

Interventions

PravastatinDRUG

Pravastatin 40 mg

Pravastatin
LifibrolDRUG

Lifibrol (K12.148; 4-(4'-tert. butylphenyl)-1-(4'-carboxyphenoxy)-2-butanol) given as a 600 mg film-coated tablet

Lifibrol

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male volunteers
  • to 35 years old
  • good clinical condition
  • normal eating habits
  • mental abilities to be able to understand the study procedures
  • written informed consent

You may not qualify if:

  • relevant pathological findings in the baseline examination
  • known allergic predisposition
  • concomitant drugs
  • alcohol or nicotine abuse
  • participation in other clinical trials in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Clinical Pharmacology, University of Bonn

Bonn, 53105, Germany

Location

MeSH Terms

Conditions

HypercholesterolemiaHyperlipoproteinemias

Interventions

Pravastatinlifibrol

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Heiner K. Berthold, Professor

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

January 1, 1996

Primary Completion

April 1, 1996

Study Completion

June 1, 1998

Last Updated

January 27, 2010

Record last verified: 2010-01

Locations

DE(1)