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
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 1999
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedApril 9, 2020
April 1, 2020
5 months
October 22, 2015
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics
Cmax
29 days
Pharmacokinetcis
Area Under the Curve (AUC)
29 days
Secondary Outcomes (4)
Plasma lipid levels - percent change from baseline at Day 29
29 days
Adverse Events
29 days
ECG
29 days
Clinical Laboratory - hematology, chemistry
29 days
Study Arms (6)
Gemcabene 50 mg
EXPERIMENTALGemcabene 50 mg
Gemcabene 150 mg
EXPERIMENTALGemcabene 150 mg
Gemcabene 450 mg
EXPERIMENTALGemcabene 450 mg
Gemcabene 750/600 mg
EXPERIMENTALGemcabene 750/600 mg
Gemcabene 900 mg
EXPERIMENTALGemcabene 900 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
- Body weight: 60-100 kg (desirable)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 27, 2015
Study Start
April 1, 1999
Primary Completion
September 1, 1999
Study Completion
September 1, 1999
Last Updated
April 9, 2020
Record last verified: 2020-04