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
Verified date | April 2020 |
Source | NeuroBo Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NeuroBo Pharmaceuticals Inc. |
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 |
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