Advertisement

Topics

A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics

2014-07-23 21:11:32 | BioPortfolio

Summary

The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Hepatic Impairment

Intervention

safinamide, safinamide, safinamide

Location

CRS Clinical Research Services Kiel GmbH
Kiel
Germany

Status

Completed

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:32-0400

Clinical Trials [735 Associated Clinical Trials listed on BioPortfolio]

A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics

The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is t...

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in pa...

Safinamide Steady State Interaction With Rosuvastatine

To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered ...

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers

To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with resp...

Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

The purpose of this research trial is to determine in Parkinson's disease patients if safinamide (experimental drug) can attenuate the dyskinesia induced by levodopa. The word "experimenta...

PubMed Articles [3533 Associated PubMed Articles listed on BioPortfolio]

Formulary Drug Review: Safinamide.

Safinamide (Xadago) for Parkinson's disease.

Pharmacokinetics and Safety of Momelotinib in Subjects With Hepatic or Renal Impairment.

Momelotinib is a Janus kinase 1/2 inhibitor in clinical development for the treatment of myelofibrosis. Two phase 1 open-label, parallel-group, adaptive studies were conducted to evaluate the pharmaco...

Medical and surgical management of advanced Parkinson's disease.

Advanced Parkinson's disease is characterized by the presence of motor fluctuations, various degree of dyskinesia, and disability with functional impact on activities of daily living and independence....

Pharmacokinetics of Rolapitant in Patients With Mild to Moderate Hepatic Impairment.

Rolapitant is a selective and long-acting neurokinin-1 receptor antagonist approved in an oral formulation in combination with other antiemetic agents for the prevention of delayed chemotherapy-induce...

Medical and Biotech [MESH] Definitions

Cholangiocarcinoma arising near or at the confluence of the right and left hepatic ducts (COMMON HEPATIC DUCT). These tumors are generally small, sharply localized, and seldom metastasizing.

A group of metabolic diseases due to deficiency of one of a number of LIVER enzymes in the biosynthetic pathway of HEME. They are characterized by the accumulation and increased excretion of PORPHYRINS or its precursors. Clinical features include neurological symptoms (PORPHYRIA, ACUTE INTERMITTENT), cutaneous lesions due to photosensitivity (PORPHYRIA CUTANEA TARDA), or both (HEREDITARY COPROPORPHYRIA). Hepatic porphyrias can be hereditary or acquired as a result of toxicity to the hepatic tissues.

A class of nongenotoxic CARCINOGENS that induce the production of hepatic PEROXISOMES and induce hepatic neoplasms after long-term administration.

A rare autosomal recessive disorder of the urea cycle. It is caused by a deficiency of the hepatic enzyme ARGINASE. Arginine is elevated in the blood and cerebrospinal fluid, and periodic HYPERAMMONEMIA may occur. Disease onset is usually in infancy or early childhood. Clinical manifestations include seizures, microcephaly, progressive mental impairment, hypotonia, ataxia, spastic diplegia, and quadriparesis. (From Hum Genet 1993 Mar;91(1):1-5; Menkes, Textbook of Child Neurology, 5th ed, p51)

Professionals skilled at diagnostic testing of hearing, HEARING IMPAIRMENT, and CORRECTION OF HEARING IMPAIRMENT by non-medical or non-surgical means.

More From BioPortfolio on "A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Hepatology
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial