Trial | NCT02587364  Report issue

Title

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers
An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gemcabene ...

  • Study Participants

    50
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
Study Started
Apr 30
1999
Primary Completion
Sep 30
1999
Study Completion
Sep 30
1999
Last Update
Apr 09
2020

Drug Gemcabene 50 mg

Gemcabene 50 mg once daily (QD)

Drug Gemcabene 150 mg

Gemcabene 150 mg once daily (QD)

Drug Gemcabene 450 mg

Gemcabene 450 mg once daily (QD)

Drug Gemcabene 750/600 mg

Gemcabene 750/600 mg once daily (QD)

Drug Gemcabene 900 mg

Gemcabene 900 mg once daily (QD)

Drug Placebo

Placebo once daily (QD)

Gemcabene 50 mg Experimental

Gemcabene 50 mg

Gemcabene 150 mg Experimental

Gemcabene 150 mg

Gemcabene 450 mg Experimental

Gemcabene 450 mg

Gemcabene 750/600 mg Experimental

Gemcabene 750/600 mg

Gemcabene 900 mg Experimental

Gemcabene 900 mg

Placebo Placebo Comparator

Placebo

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
No Results Posted