A5073909248- Pharmacogenetics and Drug Metabolism
- Asthma and respiratory diseases
- Pharmacological Effects and Toxicity Studies
- Dermatology and Skin Diseases
- Epilepsy research and treatment
- Antibiotics Pharmacokinetics and Efficacy
- Drug Transport and Resistance Mechanisms
- Inflammatory Bowel Disease
- Allergic Rhinitis and Sensitization
- Pharmaceutical studies and practices
- Psoriasis: Treatment and Pathogenesis
- Monoclonal and Polyclonal Antibodies Research
- Cardiac electrophysiology and arrhythmias
- Autoimmune Bullous Skin Diseases
- Health Systems, Economic Evaluations, Quality of Life
- Cytokine Signaling Pathways and Interactions
- Urticaria and Related Conditions
- Chronic Lymphocytic Leukemia Research
- Colorectal Cancer Treatments and Studies
- Microscopic Colitis
- Analytical Methods in Pharmaceuticals
- Mast cells and histamine
- Respiratory and Cough-Related Research
- Immunodeficiency and Autoimmune Disorders
- Hormonal and reproductive studies
Pfizer (United States)
2016-2025
Baldwin–Wallace College
2021
University of Florida
2018
Columbus Oncology and Hematology Associates
2018
Amgen (United States)
2006-2015
Wallace Laboratories
1996
CNS Research (United States)
1996
Jagiellonian University
1996
Kempenhaeghe
1995
University of Eastern Finland
1995
The vanilloid receptor TRPV1 has been identified as a molecular target for the treatment of pain associated with inflammatory diseases and cancer. Hence, antagonists have considered therapeutic evaluation in such diseases. During Phase I clinical trials AMG 517, highly selective antagonist, we found that blockade elicited marked, but reversible, generally plasma concentration-dependent hyperthermia. Similar to what was observed rats, dogs, monkeys, hyperthermia attenuated after repeated...
AMG 108 is a fully human, immunoglobulin subclass G2 (IgG2) monoclonal antibody that binds the human interleukin-1 (IL-1) receptor type 1, inhibiting activity of IL-1a and IL-1b. In preclinical studies, IL-1 inhibition was shown to be beneficial in models osteoarthritis (OA). The purpose this two-part study evaluate safety pharmacokinetics (PK; Part A) clinical effect (Part B) double-blind, placebo-controlled, multiple-dose patients with OA knee. A, received placebo or subcutaneously (SC; 75...
BackgroundAlopecia areata (AA) is an autoimmune form of hair loss with limited treatments.ObjectiveTo evaluate the efficacy and safety Janus kinase inhibitors ritlecitinib brepocitinib in patients who have AA ≥ 50% scalp loss.MethodsPatients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary endpoint was a 24-week change from baseline Severity Alopecia Tool (SALT) score. key secondary proportion achieving 30% improvement SALT score (SALT30).ResultsThe placebo...
ABSTRACT One of the most challenging issues in design phase II/III clinical trials antimicrobial agents is dose selection. The choice often based on preclinical data from pharmacokinetic (PK) studies with animals and healthy volunteers but rarely linked directly to target organisms except by MIC, an vitro measure activity many limitations. It thesis this paper that rational dose-selection decisions can be made basis pharmacodynamics (PDs) test agent predicted a mathematical model which uses...
Abstract The safety, tolerability, pharmacokinetics, and pharmacodynamics of PF‐06700841 were assessed in a randomized, double‐blind, placebo‐controlled, single‐ multiple‐dose escalation, parallel‐group study healthy subjects patients with plaque psoriasis. single ascending dose (1, 3, 10, 30, 100, or 200 mg) multiple (MAD; PF‐06700841; up to 175 mg once daily 50 twice for 10 days) periods included 54 participants. In addition, 30 psoriasis received 100 placebo 28 days. Single doses rapidly...
Janus kinase (JAK) inhibitors have shown encouraging results in the treatment of alopecia areata (AA), an autoimmune form hair loss, small, uncontrolled studies and case reports.We conducted a biopsy substudy during randomized, double-blind, placebo-controlled first 24 weeks phase 2a clinical trial that evaluated efficacy safety ritlecitinib, inhibitor JAK3 tyrosine expressed hepatocellular carcinoma (TEC) family, brepocitinib, 2 (TYK2)/JAK1 AA.Change biomarkers lesional scalp samples...
Atopic dermatitis (AD) is a prevalent inflammatory, pruritic skin disease. The Janus kinase (JAK) pathway treatment target.To assess the efficacy, safety and pharmacokinetics of topical cream brepocitinib, small-molecule tyrosine 2 (TYK2)/JAK1 inhibitor, in participants with mild-to-moderate AD.In this phase IIb, double-blind, dose-ranging study, were randomized to receive one eight treatments for 6 weeks: brepocitinib 0·1% once daily (QD), 0·3% QD or twice (BID), 1·0% BID, 3·0% QD, vehicle...
BackgroundHidradenitis suppurativa (HS) is a debilitating, inflammatory skin disease with limited treatment options and partially understood pathophysiology. Using an umbrella trial design, three kinase inhibitor immunomodulators different mechanisms of action were evaluated.MethodsThis phase 2a, double-blind, parallel-group enrolled adults moderate to severe HS who then randomly assigned (1:1:1:1) once-daily brepocitinib 45 mg (a JAK1/TYK2 inhibitor), zimlovisertib 400 (an IRAK4...
The pharmacokinetics and urinary metabolic profile of R S‐warfarin, following administration a 1.5 mg/kg oral dose racemic warfarin, alone 4 days into an regimen 100 mg phenylbutazone three times day, was investigated in volunteers using stereospecific h.p.l.c. fluorescent assay. mean elimination half‐ life S‐warfarin increased from 25 to 46 h during administration, whilst that the R‐isomer decreased 37 h. peak unbound concentrations both warfarin enantiomers were higher due displacement....
PF‐04965842 is an oral Janus kinase 1 inhibitor being investigated for the treatment of plaque psoriasis. To evaluate efficacy, safety and tolerability in patients with moderate‐to‐severe Patients this phase II, placebo‐controlled study (NCT02201524) were randomized to receive placebo, 200 mg once daily (OD), 400 OD or twice (TD) 4 weeks. The primary endpoint was change from baseline Psoriasis Area Severity Index (PASI) at week 4. Study enrolment discontinued on 25 June 2015 due changes...
Objective To evaluate the efficacy and safety of PF‐06651600 (ritlecitinib), an irreversible inhibitor JAK3 tyrosine kinase expressed in hepatocellular carcinoma (TEC) family, comparison with placebo patients rheumatoid arthritis (RA). Methods An 8‐week, phase II, double‐blind, parallel‐group study was conducted. Seventy who were seropositive for anti–citrullinated protein antibodies and/or factor randomized 3:2 to receive oral (200 mg once daily) or 8 weeks. Eligible had inadequate response...
Objective To assess the safety and immunologic impact of inhibiting interferon‐γ (IFNγ) with AMG 811, a human IgG1 monoclonal antibody against IFNγ, in patients systemic lupus erythematosus (SLE). Methods Twenty‐six mild‐to‐moderate, stable SLE were administered placebo or single dose ranging from 2 mg to 180 subcutaneously 60 intravenously. Results Similar results previously reported following inhibition type I IFNs, treatment 811 led dose‐dependent modulation expression genes associated...
Plaque psoriasis (PsO) is an inflammatory skin disease driven, in part, by the activation of Janus kinase (JAK) signalling pathways.To assess efficacy and safety multiple doses topical brepocitinib, a tyrosine 2/JAK1 inhibitor, participants with mild-to-moderate PsO.This phase IIb multicentre randomized double-blind study was conducted two stages. In stage 1, received one eight treatments for 12 weeks: brepocitinib 0.1% once daily, 0.3% or twice 1.0% 3.0% vehicle daily. 2, daily The primary...
The effects of felbamate on the pharmacokinetics a low-dose combination oral contraceptive containing 30 μg ethinyl estradiol and 75 gestodene were assessed in randomized, double-blind, placebo-controlled parallel-group study healthy premenopausal female volunteers established regimen use. They received either placebo or 2400 mg/day from midcycle (day 15) to 14) two consecutive cycles (months 1 2). Pharmacokinetic assessments performed day 14 both cycles. To determine whether ovulation...
Aims To determine the safety, tolerability, pharmacokinetics and pharmacodynamics of Janus kinase 1‐selective inhibitor, PF‐04965842. Methods This was a phase 1, first‐in‐human, randomized, double‐blind, placebo‐controlled, combination single‐ multiple‐dose escalation, parallel design study in healthy subjects ( http://clinicaltrials.gov , NCT01835197). Subjects received single dose placebo or 3, 10, 30, 100, 200, 400 800 mg PF‐04965842 (single ascending phase) 30 once daily (QD), 100 QD,...