Back to resultsEffect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Gemcabene 900 mg
Simvastatin 80 mg
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring Pharmacokinetics, Lipid Regulator
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gemcabene 900 mg
Simvastatin 80 mg
Arm Description
Gemcabene 900 mg
Simvastatin 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
NCT ID
NCT02587390
First Posted
October 22, 2015
Last Updated
April 8, 2020
Sponsor
NeuroBo Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02587390
Brief Title
Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers
Official Title
A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
July 2000 (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 simvastatin 80 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
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 900 mg
Arm Type
Experimental
Arm Description
Gemcabene 900 mg
Arm Title
Simvastatin 80 mg
Arm Type
Active Comparator
Arm Description
Simvastatin 80 mg
Intervention Type
Drug
Intervention Name(s)
Gemcabene 900 mg
Intervention Description
3x300 mg Gemcabene tablets orally once daily (QD) for 15 days
Intervention Type
Drug
Intervention Name(s)
Simvastatin 80 mg
Intervention Description
2x40 mg Simvastatin tablets orally once daily (QD) for 15 days
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
Cmax
Time Frame
15 days
Title
Pharmacokinetics
Description
Area Under the Curve (AUC)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
57 days
Title
Clinical Laboratory - hematology, chemistry, urinalysis
Description
Clinical Laboratory Abnormalities
Time Frame
57 days
Title
ECG
Description
Clinically Significant Changes
Time Frame
57 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers
We'll reach out to this number within 24 hrs