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CompletedNCT02587364Updated Apr 9, 2020

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

A Phase 1 interventional study of Gemcabene 50 mg and Gemcabene 150 mg in Hypercholesterolemia, sponsored by NeuroBo Pharmaceuticals Inc.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by NeuroBo Pharmaceuticals Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • Pharmacokinetics
  • Lipid Regulator
03

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

NeuroBo Pharmaceuticals Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Gemcabene 50 mg

    Gemcabene 50 mg

    Drug: Gemcabene 50 mg

  • Experimental
    Gemcabene 150 mg

    Gemcabene 150 mg

    Drug: Gemcabene 150 mg

  • Experimental
    Gemcabene 450 mg

    Gemcabene 450 mg

    Drug: Gemcabene 450 mg

  • Experimental
    Gemcabene 750/600 mg

    Gemcabene 750/600 mg

    Drug: Gemcabene 750/600 mg

  • Experimental
    Gemcabene 900 mg

    Gemcabene 900 mg

    Drug: Gemcabene 900 mg

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics

    Cmax

    Time frame: 29 days

  2. Pharmacokinetcis

    Area Under the Curve (AUC)

    Time frame: 29 days

Secondary outcomes

  1. Plasma lipid levels - percent change from baseline at Day 29

    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)

    Time frame: 29 days

  2. Adverse Events

    Time frame: 29 days

  3. ECG

    Clinically Significant Changes

    Time frame: 29 days

  4. Clinical Laboratory - hematology, chemistry

    Clinical Laboratory Abnormalities

    Time frame: 29 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02587364
Lead sponsor
NeuroBo Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Oct 27, 2015
Start date
Apr 1999
Primary completion
Sep 1999
Completion
Sep 1999
Last update
Apr 9, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Gemcabene

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