Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

April 8, 2020 updated by: NeuroBo Pharmaceuticals Inc.

A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcabene 900 mg
Drug: Gemcabene 900 mg
3x300 mg Gemcabene tablets orally once daily (QD) for 15 days
Drug: Simvastatin 80 mg
2x40 mg Simvastatin tablets orally once daily (QD) for 15 days
Active Comparator: Simvastatin 80 mg
Drug: Simvastatin 80 mg
2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 15 days
Cmax
15 days
Pharmacokinetics
Time Frame: 15 days
Area Under the Curve (AUC)
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 57 days
57 days
Clinical Laboratory - hematology, chemistry, urinalysis
Time Frame: 57 days
Clinical Laboratory Abnormalities
57 days
ECG
Time Frame: 57 days
Clinically Significant Changes
57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroBo Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

July 1, 2000

Study Completion (Actual)

July 1, 2000

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1027-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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