Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Gemcabene 150 mg; Drug: Placebo; Drug: Gemcabene 900 mg; Drug: Gemcabene 450 mg; Drug: Gemcabene 750/600 mg; Drug: Gemcabene 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02587364

1027-003

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 6 patient groups, including a placebo group

Gemcabene 50 mg

Experimental group

Description:

Gemcabene 50 mg

Treatment:

Drug: Gemcabene 50 mg

Gemcabene 150 mg

Experimental group

Description:

Gemcabene 150 mg

Treatment:

Drug: Gemcabene 150 mg

Gemcabene 450 mg

Experimental group

Description:

Gemcabene 450 mg

Treatment:

Drug: Gemcabene 450 mg

Gemcabene 750/600 mg

Experimental group

Description:

Gemcabene 750/600 mg

Treatment:

Drug: Gemcabene 750/600 mg

Gemcabene 900 mg

Experimental group

Description:

Gemcabene 900 mg

Treatment:

Drug: Gemcabene 900 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo