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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:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02587390
First received: October 22, 2015
Last updated: October 23, 2015
Last verified: October 2015
  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: 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

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
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, see Learn About Clinical Studies.

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
Study First Received: October 22, 2015
Last Updated: October 23, 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

ClinicalTrials.gov processed this record on July 26, 2017