Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

Hypercholesteremia Clinical Trial

Official title:

A Study of the Effect of Oral, Multiple‐Dose 300 mg and 900 mg Gemcabene (CI‐1027) Administration on the Steady‐State Pharmacokinetics of Atorvastatin 80 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587416
• Other study ID #: A4141002
• Status: Completed
• Phase: Phase 1
• Start date: November 2002
• Est. completion date: December 2002

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 atorvastatin 80 mg

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and Females

• 18-65 years of age

• Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;

• Body weight 45 kg or greater, with a body mass index (BMI) = 35 kg/m² (weight [kg]/height[meters]²)

Exclusion Criteria:

• If female, of childbearing potential or lactation

• History of significant adverse reaction to any lipid-lowering agent

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Drug:
• Gemcabene 300 mg
1x300 mg gemcabene tablets orally once daily (QD) for 11 days
• Gemcabene 900 mg
3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
• Atorvastatin
2x40 mg Atorvastatin tablets orally 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	Days 5, 16 and 27
Primary	Pharmacokinetics	Area Under the Curve (AUC)	Days 5, 16, and 27
Secondary	Adverse Events		27 days
Secondary	Clinical Laboratory - hematology, chemistry, urinalysis	Clinical Laboratory Abnormalities	27 days
Secondary	ECG	Clinically Significant Changes	27 days