A5025337220- Analytical Chemistry and Chromatography
- HIV/AIDS drug development and treatment
- Drug Solubulity and Delivery Systems
- HIV/AIDS Research and Interventions
- Advanced Drug Delivery Systems
- Drug Transport and Resistance Mechanisms
- Pharmacological Effects and Toxicity Studies
- NF-κB Signaling Pathways
- Pregnancy and Medication Impact
- Innovative Microfluidic and Catalytic Techniques Innovation
- Adenosine and Purinergic Signaling
- Pharmacogenetics and Drug Metabolism
- HIV Research and Treatment
- Pneumocystis jirovecii pneumonia detection and treatment
- Computational Drug Discovery Methods
- Microfluidic and Capillary Electrophoresis Applications
- Tryptophan and brain disorders
- Biotin and Related Studies
- Crystallization and Solubility Studies
- Cholinesterase and Neurodegenerative Diseases
- Advancements in Transdermal Drug Delivery
- Plant-based Medicinal Research
- Analytical Methods in Pharmaceuticals
- Pharmaceutical studies and practices
Janssen (Belgium)
2018-2024
Liechtenstein Institute
2023
John Wiley & Sons (United States)
2023
Hudson Institute
2023
Vrije Universiteit Brussel
2003-2004
Background: Central nervous system-derived interleukin-1β plays a role in mood disorders. P2X7 receptor activation by adenosine-triphosphate leads to the release of interleukin-1β. Aims: This first-in-human study evaluated safety, tolerability, pharmacokinetics and pharmacodynamics novel central system-penetrant antagonist, JNJ-54175446, healthy participants. Methods: The had three parts: an ascending-dose fasted participants (0.5–300 mg JNJ-54175446); fed (50–600 mg); cerebrospinal fluid...
The objective of this study was to evaluate in vitro and vivo drug release from situ forming gels prepared with poloxamer 338 (P338) and/or 407 (P407) N-methyl-2-pyrrolidone (NMP)/water mixtures for the model compound bedaquiline fumarate salt. impact total concentration (20%–25% (w/w)), P338/P407 ratio (100/0%–0/100% (w/w)) NMP/water (0/100%–25/75% (v/v)) on gel point temperature (GPT) investigated via a design experiments (DoE), showing that GPT decreased mainly increasing decreasing...
Background: Rilpivirine has shown adequate antiviral activity, consistent pharmacokinetics and safety in adults adolescents living with HIV-1. Pharmacokinetics, safety, activity of rilpivirine were assessed children, following at least 48 weeks treatment. Methods: Cohort 2 the open-label, phase PAINT study (NCT00799864) included antiretroviral-naïve children HIV-1 ≥6 to <12 years old, a viral load ≤100,000 RNA copies/mL. Participants received weight-based doses combination background...
The aim of the presented retrospective analysis was to verify whether a previously proposed Janssen Biopharmaceutical Classification System (BCS)-like decision tree, based on preclinical bioavailability data solution and suspension formulation, would facilitate informed making clinical formulation development strategy. In addition, predictive value (in vitro) selection criteria, such as solubility, human permeability, and/or dose number (Do), were evaluated, potentially reducing additional...
Introduction: MALT1 is a key component of the CARD11-BCL10-MALT1 (CBM) complex, which activates classical NF-κB pathway. JNJ-67856633 (JNJ-6633), highly selective protease inhibitor CBM-mediated signaling, demonstrated potent anti-lymphoma activity in preclinical models. Here, we present results from phase 1 dose escalation study JNJ-6633 patients (pts) with R/R B-NHL and CLL. Methods: Pts were ≥18 years or CLL (per WHO/iwCLL criteria), ECOG PS ≤1, ≥1 2 lines therapy (LOT). Dose was...
Abstract Objective Darunavir (DRV) is a P-glycoprotein (P-gp) inhibitor. Dabigatran etexilate, prodrug of the anticoagulant dabigatran, P-gp probe substrate. This study evaluated effect single and multiple doses DRV, coadministered with cobicistat (COBI) or ritonavir (rtv), on pharmacokinetics (PK) single-dose dabigatran etexilate. Methods was an open-label, fixed-sequence, single-center, 2-panel, phase 1 in which healthy adult participants were equally divided over 2 panels. In panel 1,...
This study evaluated in vitro and vivo drug release of bedaquiline from situ forming gels (ISGs) containing 200 mg eq./g fumarate salt prepared with four different grades poly(d,l-lactide) (PDLLA) or poly(d,l-lactide-co-glycolide) (PLGA) a lactide/glycolide ratio 50/50 75/25 acid (A) ester (E) end-capping N-methyl-2-pyrrolidone at polymer/solvent 20/80% (w/w). Mean 0.05 M phosphate buffer pH 7.4 1% (w/v) sodium lauryl sulphate was 37.3, 47.1, 53.3, 62.3% within 28 days for ISGs PLGA5050A,...
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a fixed-dose combination (FDC) for the treatment of HIV-1 infection in adults and adolescents weighing 40 kg or greater. This Phase 1, randomized, open-label, 2-treatment, 2-sequence, 4-period replicate crossover study (NCT04661397) evaluated pivotal bioequivalence pediatric D/C/F/TAF 675/150/200/10-mg FDC compared with coadministration separate commercially available formulations healthy under fed...
Background Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed swallowability and acceptability long-term use of scored placebo tablets matching D/C/F/TAF FDC in children living with HIV-1. Methods (NCT04006704) Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence...
Background: MALT1 (mucosa-associated lymphoid tissue lymphoma translocation protein 1) is a key component of the CARD11-BCL10-MALT1 (CBM) complex, which activates classical NF-κB pathway. JNJ-67856633, highly selective protease inhibitor CBM-mediated signaling, has demonstrated potent anti-lymphoma activity preclinically in vitro and vivo. Aims: To present results from phase 1, first-in-human dose escalation study (NCT03900598) JNJ-67856633 patients (pts) with R/R B-NHL CLL. Methods:...