Overview

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Status:
Completed
Trial end date:
1999-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Gemphire Therapeutics, Inc.
NeuroBo Pharmaceuticals Inc.
Criteria
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