Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02587364

Enrollment

Registered

2015-10-27

Start date

1999-04-30

Completion date

1999-09-30

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 evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

Interventions

DRUGGemcabene 50 mg

Gemcabene 50 mg once daily (QD)

DRUGGemcabene 150 mg

Gemcabene 150 mg once daily (QD)

DRUGGemcabene 450 mg

Gemcabene 450 mg once daily (QD)

DRUGGemcabene 750/600 mg

Gemcabene 750/600 mg once daily (QD)

DRUGGemcabene 900 mg

Gemcabene 900 mg once daily (QD)

DRUGPlacebo

Placebo once daily (QD)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments * Body weight: 60-100 kg (desirable)

Exclusion criteria

* Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ; * Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1); * If female, of childbearing potential or lactating; * History of significant reaction to any fibrate lipid-lowering agent; and * Significant urine collection of any drug which could interfere with the study

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetcis	29 days	Area Under the Curve (AUC)
Pharmacokinetics	29 days	Cmax

Secondary

Measure	Time frame	Description
Plasma lipid levels - percent change from baseline at Day 29	29 days	percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Adverse Events	29 days	—
ECG	29 days	Clinically Significant Changes
Clinical Laboratory - hematology, chemistry	29 days	Clinical Laboratory Abnormalities

Outcome results

None listed

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