Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02587390

Enrollment

Registered

2015-10-27

Start date

2000-05-31

Completion date

2000-07-31

Last updated

2020-04-09

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

Conditions

Hypercholesterolemia

Keywords

Pharmacokinetics, Lipid Regulator

Brief summary

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

Interventions

DRUGGemcabene 900 mg

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

DRUGSimvastatin 80 mg

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	15 days	Cmax

Secondary

Measure	Time frame	Description
Adverse Events	57 days	—
Clinical Laboratory - hematology, chemistry, urinalysis	57 days	Clinical Laboratory Abnormalities
ECG	57 days	Clinically Significant Changes

Outcome results

None listed

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