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Trial record 1 of 1 for:    NCT02587364
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Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02587364
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 evaluate the multiple‐dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

Condition Intervention Phase
Hypercholesterolemia Drug: Gemcabene 50 mg Drug: Gemcabene 150 mg Drug: Gemcabene 450 mg Drug: Gemcabene 750/600 mg Drug: Gemcabene 900 mg Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: An Oral, Rising, Multiple‐Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

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

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 29 days ]
    Cmax

  • Pharmacokinetcis [ Time Frame: 29 days ]
    Area Under the Curve (AUC)


Secondary Outcome Measures:
  • Plasma lipid levels - percent change from baseline at Day 29 [ Time Frame: 29 days ]
    percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)

  • Adverse Events [ Time Frame: 29 days ]
  • ECG [ Time Frame: 29 days ]
    Clinically Significant Changes

  • Clinical Laboratory - hematology, chemistry [ Time Frame: 29 days ]
    Clinical Laboratory Abnormalities


Enrollment: 50
Study Start Date: April 1999
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcabene 50 mg
Gemcabene 50 mg
Drug: Gemcabene 50 mg
Gemcabene 50 mg once daily (QD)
Experimental: Gemcabene 150 mg
Gemcabene 150 mg
Drug: Gemcabene 150 mg
Gemcabene 150 mg once daily (QD)
Experimental: Gemcabene 450 mg
Gemcabene 450 mg
Drug: Gemcabene 450 mg
Gemcabene 450 mg once daily (QD)
Experimental: Gemcabene 750/600 mg
Gemcabene 750/600 mg
Drug: Gemcabene 750/600 mg
Gemcabene 750/600 mg once daily (QD)
Experimental: Gemcabene 900 mg
Gemcabene 900 mg
Drug: Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo once daily (QD)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
  • Body weight: 60‐100 kg (desirable)

Exclusion Criteria:

  • Use of any medication not considered acceptable by the clinical investigators during the 14‐day period before the start of the study (Day 1) ;
  • Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30‐day period before the start of the study (Day 1);
  • If female, of childbearing potential or lactating;
  • History of significant reaction to any fibrate lipid‐lowering agent; and
  • Significant urine collection of any drug which could interfere with the study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02587364     History of Changes
Other Study ID Numbers: 1027-003
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