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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

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ClinicalTrials.gov Identifier: NCT02587390
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

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 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
Actual Primary Completion Date : July 2000
Actual Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

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

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



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

  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



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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

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.:
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