Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

1999-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

NCT02587390

Hypercholesterolemia

COMPLETED PHASE1

A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers

NCT01147887

Healthy

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects

NCT06094790

Healthy

COMPLETED PHASE1

Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants

NCT01106469

Healthy

COMPLETED PHASE1

Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones

NCT00576589

Obesity

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gemcabene 50 mg

Group Type EXPERIMENTAL

Gemcabene 50 mg

Intervention Type DRUG

Gemcabene 50 mg once daily (QD)

Gemcabene 150 mg

Group Type EXPERIMENTAL

Gemcabene 150 mg

Intervention Type DRUG

Gemcabene 150 mg once daily (QD)

Gemcabene 450 mg

Group Type EXPERIMENTAL

Gemcabene 450 mg

Intervention Type DRUG

Gemcabene 450 mg once daily (QD)

Gemcabene 750/600 mg

Group Type EXPERIMENTAL

Gemcabene 750/600 mg

Intervention Type DRUG

Gemcabene 750/600 mg once daily (QD)

Gemcabene 900 mg

Group Type EXPERIMENTAL

Gemcabene 900 mg

Intervention Type DRUG

Gemcabene 900 mg once daily (QD)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily (QD)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemcabene 50 mg

Gemcabene 50 mg once daily (QD)

Intervention Type DRUG

Gemcabene 150 mg

Gemcabene 150 mg once daily (QD)

Intervention Type DRUG

Gemcabene 450 mg

Gemcabene 450 mg once daily (QD)

Intervention Type DRUG

Gemcabene 750/600 mg

Gemcabene 750/600 mg once daily (QD)

Intervention Type DRUG

Gemcabene 900 mg

Gemcabene 900 mg once daily (QD)

Intervention Type DRUG

Placebo

Placebo once daily (QD)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes