NCT02587390

Brief Summary

The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2000

Shorter than P25 for phase_1

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, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

October 22, 2015

Last Update Submit

April 8, 2020

Conditions

Hypercholesterolemia

Keywords

PharmacokineticsLipid Regulator

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics

    Cmax

    15 days

  • Pharmacokinetics

    Area Under the Curve (AUC)

    15 days

Secondary Outcomes (3)

  • Adverse Events

    57 days

  • Clinical Laboratory - hematology, chemistry, urinalysis

    57 days

  • ECG

    57 days

Study Arms (2)

Gemcabene 900 mg

EXPERIMENTAL

Gemcabene 900 mg

Drug: Gemcabene 900 mgDrug: Simvastatin 80 mg

Simvastatin 80 mg

ACTIVE COMPARATOR

Simvastatin 80 mg

Drug: Simvastatin 80 mg

Interventions

Gemcabene 900 mgDRUG

3x300 mg Gemcabene tablets orally once daily (QD) for 15 days

Gemcabene 900 mg
Simvastatin 80 mgDRUG

2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Gemcabene 900 mgSimvastatin 80 mg

Eligibility Criteria

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

You may qualify if:

  • Males and Females
  • \>18 years of age
  • Body weight 45 kg or greater

You may not qualify if:

  • If female, of childbearing potential or lactation
  • History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

gemcabeneSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

May 1, 2000

Primary Completion

July 1, 2000

Study Completion

July 1, 2000

Last Updated

April 9, 2020

Record last verified: 2020-04