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Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02587364
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
NeuroBo Pharmaceuticals Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : April 1999
Actual Primary Completion Date : September 1999
Actual Study Completion Date : September 1999
Arms and Interventions
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Arm Intervention/treatment
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)


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

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


Secondary Outcome Measures :
  1. 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)

  2. Adverse Events [ Time Frame: 29 days ]
  3. ECG [ Time Frame: 29 days ]
    Clinically Significant Changes

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


Eligibility Criteria
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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
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No Contacts or Locations Provided
More Information
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Responsible Party: NeuroBo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02587364    
Other Study ID Numbers: 1027-003
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by NeuroBo Pharmaceuticals Inc.:
Pharmacokinetics
Lipid Regulator
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases