We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02587390
Previous Study | Return to List | Next Study

Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02587390
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Gemcabene 900 mg Drug: Simvastatin 80 mg Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers
Study Start Date : May 2000
Primary Completion Date : July 2000
Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Gemcabene 900 mg
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
Simvastatin 80 mg
Drug: Simvastatin 80 mg
2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 15 days ]

  2. Pharmacokinetics [ Time Frame: 15 days ]
    Area Under the Curve (AUC)

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 57 days ]
  2. Clinical Laboratory - hematology, chemistry, urinalysis [ Time Frame: 57 days ]
    Clinical Laboratory Abnormalities

  3. ECG [ Time Frame: 57 days ]
    Clinically Significant Changes

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02587390     History of Changes
Other Study ID Numbers: 1027-008
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Gemphire Therapeutics, Inc.:
Lipid Regulator

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors