Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
Summary
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
Study Design
Conditions
Hepatic Impairment
Intervention
PF-06865571 100 mg
Status
Not yet recruiting
Source
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04091061
- ClinicalTrials.gov processed this data on September 19, 2019
Published on BioPortfolio: 2019-09-20T03:46:43-0400
Clinical Trials
Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single d...
A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects
An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fe...
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth an...
This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In a...
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be u...
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To study community pharmacists' level of knowledge on medication safety in patients with hepatic impairment and their practice in caring for these patients.
Medical and Biotech [MESH] Definitions
Klatskin Tumor
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.
Porphyrias, Hepatic
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.
Peroxisome Proliferators
A class of nongenotoxic CARCINOGENS that induce the production of hepatic PEROXISOMES and induce hepatic neoplasms after long-term administration.
Hyperargininemia
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)
Audiologists
Professionals skilled at diagnostic testing of hearing, HEARING IMPAIRMENT, and CORRECTION OF HEARING IMPAIRMENT by non-medical or non-surgical means.
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