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Study to Evaluate Darapladib in Moderately Hepatically Impaired Subjects

2014-08-27 03:12:31 | BioPortfolio

Summary

The purpose of this study is to determine any differences in pharmacokinetic parameters of darapladib when dosed to people with moderate liver disease as compared to when dosed in normal healthy volunteers.

Description

This study is an open-label, non-randomised study to assess the pharmacokinetics and safety/tolerability of repeat oral 40 mg doses of darapladib in subjects with moderate hepatic impairment (as defined by a Child-Pugh score of 7-9) in comparison to matched healthy volunteers.

The hepatically impaired and healthy volunteer groups will receive repeat oral doses of darapladib for 10 consecutive days. The pharmacokinetics of darapladib and its metabolites will be evaluated. The effect of liver impairment on the plasma protein binding of darapladib and metabolites will also be determined as data permit. Safety will be assessed by clinical laboratory tests (hematology, chemistry and urinalysis), vital signs (blood pressure and heart rate measurements), 12-lead electrocardiograms (ECGs) and monitoring for adverse events (AEs).

Subjects will be housed in the clinical unit from the evening before first dose until 24 hours after the final dose of 10 days of repeat dosing. A follow-up period will include 2 visits, one of which will be conducted approximately 10-14 days from the last dose of study drug and the second visit will be 35 days +/- one week after the last dose of study drug

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Atherosclerosis

Intervention

darapladib

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

Clinical Trials [258 Associated Clinical Trials listed on BioPortfolio]

The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

A Healthy Volunteer Pharmacokinetic Study of Single and Repeat Doses of SB-480848

This study is designed to assess the pharmacokinetics of darapladib and its metabolites following single and 28 days of repeat dosing of darapladib.

A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men

This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients

Phase I Study of SB-480848(Darapladib) -Repeat Dose Study in Healthy Japanese Male Subjects-

This study is being conducted to provide safety, tolerability, PK and PD data in repeat dosing that will allow further studies with darapladib in Japanese patients

A Study With Darapladib to Collect Tolerability Information

Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and the remaining 9 days of dosing will occur at home. Subjects will record any adverse events th...

PubMed Articles [800 Associated PubMed Articles listed on BioPortfolio]

Darapladib inhibits atherosclerosis development in type 2 diabetes mellitus Sprague-Dawley rat model.

Increase in the low-density lipoprotein (LDL) level in diabetes mellitus and atherosclerosis is related to lipoprotein associated phospholipase A2 (Lp-PLA2). Lp-PLA2 is an enzyme that produces lysopho...

Matrix metalloproteinase-10 deficiency delays atherosclerosis progression and plaque calcification.

Matrix metalloproteinases (MMPs) have been implicated in atherosclerosis and vascular calcification. Among them, we reported that MMP10 is present in human atheroma, associated with atherosclerosis. H...

Progranulin in the hematopoietic compartment protects mice from atherosclerosis.

Progranulin is a circulating protein that modulates inflammation and is found in atherosclerotic lesions. Here we determined whether inflammatory cell-derived progranulin impacts atherosclerosis devel...

Disruption of a CD1d-mediated interaction between mast cells and NKT cells aggravates atherosclerosis.

The development of atherosclerosis is tightly regulated by the innate and adaptive immune system. Communication between these two compartments occurs, among others, upon presentation of lipid antigens...

Anti-tumor necrosis factor-α therapy increases plaque burden in a mouse model of experimental atherosclerosis.

Atherosclerosis is critically fueled by vascular inflammation through oxidized lipids and inflammatory cytokines such as tumor necrosis factor (TNF)-α. Genetic disruption of Tnf-α reduces atheroscle...

Medical and Biotech [MESH] Definitions

Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.

Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.

A drug that has been given by mouth in the treatment of atherosclerosis and other vascular disorders, hyperlipidemias, and thrombo-embolic disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1408)

Strains of mice that contain genetic disruptions (knockout) of APOLIPOPROTEINS E genes. They are used as models for ATHEROSCLEROSIS research.

A measurement of the thickness of the carotid artery walls. It is measured by B-mode ULTRASONOGRAPHY and is used as a surrogate marker for ATHEROSCLEROSIS.

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