Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02587416

Enrollment

Registered

2015-10-27

Start date

2002-11-30

Completion date

2002-12-31

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

Hypercholesteremia

Keywords

Pharmacokinetics, Lipid Regulator

Brief summary

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

Interventions

DRUGGemcabene 300 mg

1x300 mg gemcabene tablets orally once daily (QD) for 11 days

DRUGGemcabene 900 mg

3x300 mg Gemcabene tablets orally once daily (QD) for 11 days

DRUGAtorvastatin

2x40 mg Atorvastatin tablets orally once daily (QD)

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Males and Females * 18-65 years of age * Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements; * Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight \[kg\]/height\[meters\]²)

Exclusion criteria

* If female, of childbearing potential or lactation * History of significant adverse reaction to any lipid-lowering agent

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	Days 5, 16 and 27	Cmax

Secondary

Measure	Time frame	Description
Adverse Events	27 days	—
Clinical Laboratory - hematology, chemistry, urinalysis	27 days	Clinical Laboratory Abnormalities
ECG	27 days	Clinically Significant Changes

Outcome results

None listed

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