Publications by authors named "J J ZACK"
Article Synopsis
- The study evaluated the effectiveness and tolerability of the antimalarial drug ganaplacide in combination with lumefantrine solid dispersion (LUM-SDF) for treating uncomplicated falciparum malaria across various age groups in a Phase II clinical trial.
- The trial consisted of three parts: a run-in phase assessing pharmacokinetic interactions, a regimen comparison in adults and adolescents, and a dosage assessment in children aged 2 to under 12 years.
- Results indicated that co-administration of ganaplacide and LUM-SDF did not significantly alter drug exposure levels, with both drugs showing adequate exposure for efficacy across different age and weight groups, despite some variability.
A drug-drug interaction (DDI) study was conducted to evaluate the effect of icenticaftor (QBW251) on the pharmacokinetics (PK) of a 5-probe cytochrome P450 (CYP) substrate cocktail, guided by in vitro studies in human hepatocytes and liver microsomes. Another DDI study investigated the effect of icenticaftor on the PK and pharmacodynamics (PD) of a monophasic oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LVG) in premenopausal healthy female subjects. The static-mechanistic DDI assessment indicated that icenticaftor may moderately induce the metabolic clearance of co-medications metabolized by CYP3A4 (area under the concentration-time curve [AUC] ratio: 0.
View Article and Find Full Text PDFBackground: Latency reversing agents (LRAs) such as protein kinase C (PKC) modulators can reduce rebound-competent HIV reservoirs in small animal models. Furthermore, administration of natural killer (NK) cells following LRA treatment improves this reservoir reduction. It is currently unknown why the combination of a PKC modulator and NK cells is so potent and whether exposure to PKC modulators may augment NK cell function in some way.
View Article and Find Full Text PDFBackground: Pre-exposure prophylaxis (PrEP) utilization among cisgender women (subsequently 'women') is low across age groups, relative to their risk of HIV acquisition. We hypothesize that age-related differences in psychosocial factors also influence women's intention to initiate oral PrEP in Washington, D.C.
View Article and Find Full Text PDFArticle Synopsis
- Omalizumab, an anti-IgE monoclonal antibody, is used to treat conditions like asthma and chronic urticaria and is available in new injection formats for better patient convenience.
- A study aimed to determine if new injection configurations (PFS-AI and PFS-NSD) were pharmacokinetically bioequivalent to the current configuration, using measurements like concentration (C) and area under the curve (AUC).
- Results showed that both new configurations met the bioequivalence criteria with confidence intervals within the acceptable range, and safety profiles were consistent with existing data on omalizumab.