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Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Gemcabene 50 mg

Gemcabene 150 mg

Gemcabene 450 mg

Gemcabene 750/600 mg

Gemcabene 900 mg

Placebo

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring Pharmacokinetics, Lipid Regulator

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Gemcabene 50 mg

Gemcabene 150 mg

Gemcabene 450 mg

Gemcabene 750/600 mg

Gemcabene 900 mg

Placebo

Arm Description

Gemcabene 50 mg

Gemcabene 150 mg

Gemcabene 450 mg

Gemcabene 750/600 mg

Gemcabene 900 mg

Placebo

Outcomes

Primary Outcome Measures

Pharmacokinetics

Cmax

Pharmacokinetcis

Area Under the Curve (AUC)

Secondary Outcome Measures

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)

Adverse Events

ECG

Clinically Significant Changes

Clinical Laboratory - hematology, chemistry

Clinical Laboratory Abnormalities

Full Information

NCT ID

NCT02587364

First Posted

October 22, 2015

Last Updated

April 8, 2020

Sponsor

NeuroBo Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02587364

Brief Title

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Official Title

An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 1999 (undefined)

Primary Completion Date

September 1999 (Actual)

Study Completion Date

September 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroBo Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Pharmacokinetics, Lipid Regulator

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcabene 50 mg

Arm Type

Experimental

Arm Description

Gemcabene 50 mg

Arm Title

Gemcabene 150 mg

Arm Type

Experimental

Arm Description

Gemcabene 150 mg

Arm Title

Gemcabene 450 mg

Arm Type

Experimental

Arm Description

Gemcabene 450 mg

Arm Title

Gemcabene 750/600 mg

Arm Type

Experimental

Arm Description

Gemcabene 750/600 mg

Arm Title

Gemcabene 900 mg

Arm Type

Experimental

Arm Description

Gemcabene 900 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Gemcabene 50 mg

Intervention Description

Gemcabene 50 mg once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Gemcabene 150 mg

Intervention Description

Gemcabene 150 mg once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Gemcabene 450 mg

Intervention Description

Gemcabene 450 mg once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Gemcabene 750/600 mg

Intervention Description

Gemcabene 750/600 mg once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Gemcabene 900 mg

Intervention Description

Gemcabene 900 mg once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo once daily (QD)

Primary Outcome Measure Information:

Title

Pharmacokinetics

Description

Cmax

Time Frame

29 days

Title

Pharmacokinetcis

Description

Area Under the Curve (AUC)

Time Frame

29 days

Secondary Outcome Measure Information:

Title

Plasma lipid levels - percent change from baseline at Day 29

Description

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

Title

Adverse Events

Time Frame

29 days

Title

ECG

Description

Clinically Significant Changes

Time Frame

29 days

Title

Clinical Laboratory - hematology, chemistry

Description

Clinical Laboratory Abnormalities

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

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