Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

• Sponsor: NeuroBo Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02587416
• Collaborator: (none)
• Enrollment: 20
• Arms: 3
• Duration (Days): 30

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg

Condition or Disease	Intervention/Treatment	Phase
Hypercholesteremia	Drug: Gemcabene 300 mg; Drug: Gemcabene 900 mg; Drug: Atorvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Dec 1, 2002
• Actual Study Completion Date: Dec 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gemcabene 300 mg Gemcabene 300 mg	Drug: Gemcabene 300 mg; 1x300 mg gemcabene tablets orally once daily (QD) for 11 days; Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD)
Experimental: Gemcabene 900 mg Gemcabene 900 mg	Drug: Gemcabene 900 mg; 3x300 mg Gemcabene tablets orally once daily (QD) for 11 days; Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD)
Active Comparator: Atorvastatin 80 mg Atorvastatin 80 mg	Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD)

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [Days 5, 16 and 27]

   Cmax

2. Pharmacokinetics [Days 5, 16, and 27]

   Area Under the Curve (AUC)

Secondary Outcome Measures

1. Adverse Events [27 days]

2. Clinical Laboratory - hematology, chemistry, urinalysis [27 days]

   Clinical Laboratory Abnormalities

3. ECG [27 days]

   Clinically Significant Changes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NeuroBo Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NeuroBo Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT02587416
• Other Study ID Numbers: A4141002
• First Posted: Oct 27, 2015
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by NeuroBo Pharmaceuticals Inc.: Pharmacokinetics; Lipid Regulator
• Additional relevant MeSH terms: Hypercholesterolemia; Atorvastatin

Study Results

No Results Posted as of Apr 9, 2020