Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Hypercholesterolemia Clinical Trial

Official title:

A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587390
• Other study ID #: 1027-008
• Status: Completed
• Phase: Phase 1
• Start date: May 2000
• Est. completion date: July 2000

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 determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2000
• Est. primary completion date: July 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and Females

• >18 years of age

• Body weight 45 kg or greater

Exclusion Criteria:

• If female, of childbearing potential or lactation

• History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Gemcabene 900 mg
3x300 mg Gemcabene tablets orally once daily (QD) for 15 days
• Simvastatin 80 mg
2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

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	15 days
Primary	Pharmacokinetics	Area Under the Curve (AUC)	15 days
Secondary	Adverse Events		57 days
Secondary	Clinical Laboratory - hematology, chemistry, urinalysis	Clinical Laboratory Abnormalities	57 days
Secondary	ECG	Clinically Significant Changes	57 days