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Trial record 1 of 1 for:    NCT02587390
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Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02587390
First Posted: October 27, 2015
Last Update Posted: October 27, 2015
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.
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
  Purpose
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Condition Intervention Phase
Hypercholesterolemia Drug: Gemcabene 900 mg Drug: Simvastatin 80 mg Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gemphire Therapeutics, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 15 days ]
    Cmax

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


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

  • ECG [ Time Frame: 57 days ]
    Clinically Significant Changes


Enrollment: 20
Study Start Date: May 2000
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02587390     History of Changes
Other Study ID Numbers: 1027-008
First Submitted: October 22, 2015
First Posted: October 27, 2015
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Gemphire Therapeutics, Inc.:
Pharmacokinetics
Lipid Regulator

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