This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT02587416
Previous Study | Return to List | Next Study

Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02587416
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 atorvastatin 80 mg

Condition Intervention Phase
Hypercholesteremia Drug: Gemcabene 300 mg Drug: Gemcabene 900 mg Drug: Atorvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Days 5, 16 and 27 ]
    Cmax

  • Pharmacokinetics [ Time Frame: Days 5, 16, and 27 ]
    Area Under the Curve (AUC)


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: November 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcabene 300 mg
Gemcabene 300 mg
Drug: Gemcabene 300 mg
1x300 mg gemcabene tablets orally once daily (QD) for 11 days
Drug: Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)
Experimental: Gemcabene 900 mg
Gemcabene 900 mg
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)
Active Comparator: Atorvastatin 80 mg
Atorvastatin 80 mg
Drug: Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT02587416     History of Changes
Other Study ID Numbers: A4141002
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
Atorvastatin Calcium
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 September 19, 2017