Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

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.
 
ClinicalTrials.gov Identifier: NCT02587416
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 27, 2015
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE November 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • Pharmacokinetics [ Time Frame: Days 5, 16 and 27 ]
    Cmax
  • Pharmacokinetics [ Time Frame: Days 5, 16, and 27 ]
    Area Under the Curve (AUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • Adverse Events [ Time Frame: 27 days ]
  • Clinical Laboratory - hematology, chemistry, urinalysis [ Time Frame: 27 days ]
    Clinical Laboratory Abnormalities
  • ECG [ Time Frame: 27 days ]
    Clinically Significant Changes
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 Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
Official Title  ICMJE A Study of the Effect of Oral, Multiple‐Dose 300 mg and 900 mg Gemcabene (CI‐1027) Administration on the Steady‐State Pharmacokinetics of Atorvastatin 80 mg
Brief Summary The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesteremia
Intervention  ICMJE
  • Drug: Gemcabene 300 mg
    1x300 mg gemcabene tablets orally once daily (QD) for 11 days
  • Drug: Gemcabene 900 mg
    3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
  • Drug: Atorvastatin
    2x40 mg Atorvastatin tablets orally once daily (QD)
Study Arms  ICMJE
  • Experimental: Gemcabene 300 mg
    Gemcabene 300 mg
    Interventions:
    • Drug: Gemcabene 300 mg
    • Drug: Atorvastatin
  • Experimental: Gemcabene 900 mg
    Gemcabene 900 mg
    Interventions:
    • Drug: Gemcabene 900 mg
    • Drug: Atorvastatin
  • Active Comparator: Atorvastatin 80 mg
    Atorvastatin 80 mg
    Intervention: Drug: Atorvastatin
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 23, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and Females
  • 18‐65 years of age
  • Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
  • Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²)

Exclusion Criteria:

  • If female, of childbearing potential or lactation
  • History of significant adverse reaction to any lipid‐lowering agent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 NCT02587416
Other Study ID Numbers  ICMJE A4141002
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