Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587364
• Other study ID #: 1027-003
• Status: Completed
• Phase: Phase 1
• Start date: April 1999
• Est. completion date: September 1999

Study information

• Verified date: April 2020
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1999
• Est. primary completion date: September 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Gemcabene 50 mg
Gemcabene 50 mg once daily (QD)
• Gemcabene 150 mg
Gemcabene 150 mg once daily (QD)
• Gemcabene 450 mg
Gemcabene 450 mg once daily (QD)
• Gemcabene 750/600 mg
Gemcabene 750/600 mg once daily (QD)
• Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
• Placebo
Placebo once daily (QD)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Cmax	29 days
Primary	Pharmacokinetcis	Area Under the Curve (AUC)	29 days
Secondary	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)	29 days
Secondary	Adverse Events		29 days
Secondary	ECG	Clinically Significant Changes	29 days
Secondary	Clinical Laboratory - hematology, chemistry	Clinical Laboratory Abnormalities	29 days