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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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ClinicalTrials.gov Identifier: NCT02586168
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 26, 2015
Last Update Posted Date October 26, 2015
Study Start Date  ICMJE July 2001
Actual Primary Completion Date October 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
Insulin sensitivity [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • Adverse Events [ Time Frame: 4 weeks ]
  • ECG [ Time Frame: 4 weeks ]
    Clinically Significant Changes
  • Clinical Laboratory - hematology, chemistry [ Time Frame: 4 weeks ]
    Clinical Laboratory Abnormalities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects
Official Title  ICMJE The Effect of Gemcabene (CI‐1027) on Insulin Sensitivity in Nondiabetic Subjects
Brief Summary The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Insulin Sensitivity
Intervention  ICMJE
  • Drug: Gemcabene 900 mg
    Gemcabene 900 mg once daily (QD)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Gemcabene 900 mg
    Gemcabene 900 mg
    Intervention: Drug: Gemcabene 900 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2015)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2001
Actual Primary Completion Date October 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
  • Males; and females of non‐reproductive potential
  • Obesity
  • Non‐diabetic

Exclusion Criteria:

  • Use of any medication considered unacceptable by the clinical investigators during the 14‐day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
  • Use of a lipid‐lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
  • Use of any anti‐diabetic medications
  • Use of any steroid medications
  • Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
  • If female, pregnant, lactating or of childbearing potential; and
  • History of significant reaction to any fibrate lipid‐lowering agent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02586168
Other Study ID Numbers  ICMJE 1027-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gemphire Therapeutics, Inc.
Study Sponsor  ICMJE Gemphire Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gemphire Therapeutics, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP