NCT02587416

Brief Summary

The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 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 Nov 2002

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

November 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
12.9 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

1 month

First QC Date

October 22, 2015

Last Update Submit

April 8, 2020

Conditions

Hypercholesteremia

Keywords

PharmacokineticsLipid Regulator

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics

    Cmax

    Days 5, 16 and 27

  • Pharmacokinetics

    Area Under the Curve (AUC)

    Days 5, 16, and 27

Secondary Outcomes (3)

  • Adverse Events

    27 days

  • Clinical Laboratory - hematology, chemistry, urinalysis

    27 days

  • ECG

    27 days

Study Arms (3)

Gemcabene 300 mg

EXPERIMENTAL

Gemcabene 300 mg

Drug: Gemcabene 300 mgDrug: Atorvastatin

Gemcabene 900 mg

EXPERIMENTAL

Gemcabene 900 mg

Drug: Gemcabene 900 mgDrug: Atorvastatin

Atorvastatin 80 mg

ACTIVE COMPARATOR

Atorvastatin 80 mg

Drug: Atorvastatin

Interventions

Gemcabene 300 mgDRUG

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

Gemcabene 300 mg
Gemcabene 900 mgDRUG

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

Gemcabene 900 mg
AtorvastatinDRUG

2x40 mg Atorvastatin tablets orally once daily (QD)

Atorvastatin 80 mgGemcabene 300 mgGemcabene 900 mg

Eligibility Criteria

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

You may qualify if:

  • Males and Females
  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

gemcabeneAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

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

November 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

April 9, 2020

Record last verified: 2020-04