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Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

Primary Purpose

Hypercholesteremia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Gemcabene 300 mg
Gemcabene 900 mg
Atorvastatin
Sponsored by
NeuroBo Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesteremia focused on measuring Pharmacokinetics, Lipid Regulator

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Gemcabene 300 mg

    Gemcabene 900 mg

    Atorvastatin 80 mg

    Arm Description

    Gemcabene 300 mg

    Gemcabene 900 mg

    Atorvastatin 80 mg

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics
    Cmax
    Pharmacokinetics
    Area Under the Curve (AUC)

    Secondary Outcome Measures

    Adverse Events
    Clinical Laboratory - hematology, chemistry, urinalysis
    Clinical Laboratory Abnormalities
    ECG
    Clinically Significant Changes

    Full Information

    First Posted
    October 22, 2015
    Last Updated
    April 8, 2020
    Sponsor
    NeuroBo Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02587416
    Brief Title
    Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    December 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NeuroBo Pharmaceuticals Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesteremia
    Keywords
    Pharmacokinetics, Lipid Regulator

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gemcabene 300 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 300 mg
    Arm Title
    Gemcabene 900 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 900 mg
    Arm Title
    Atorvastatin 80 mg
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin 80 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 300 mg
    Intervention Description
    1x300 mg gemcabene tablets orally once daily (QD) for 11 days
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 900 mg
    Intervention Description
    3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Intervention Description
    2x40 mg Atorvastatin tablets orally once daily (QD)
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics
    Description
    Cmax
    Time Frame
    Days 5, 16 and 27
    Title
    Pharmacokinetics
    Description
    Area Under the Curve (AUC)
    Time Frame
    Days 5, 16, and 27
    Secondary Outcome Measure Information:
    Title
    Adverse Events
    Time Frame
    27 days
    Title
    Clinical Laboratory - hematology, chemistry, urinalysis
    Description
    Clinical Laboratory Abnormalities
    Time Frame
    27 days
    Title
    ECG
    Description
    Clinically Significant Changes
    Time Frame
    27 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

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