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更新于：2026-05-02
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更新于：2026-05-02
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NCT07290777
A Phase 2, Randomized, Partially Blinded, Controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VEL-101 in Kidney Transplant Recipients.
NCT06751992
Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
NCT07479836
OPTImizing Ventilation to Improve Survival From Out-of-Hospital Cardiac Arrest: The OPTIVO Randomized Controlled Trial
100 项与 Asahi Kasei Corp. 相关的临床结果
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2026-02-01PHARMACEUTICAL RESEARCH
Intracerebral Distribution of Drugs with Diverse Blood–brain Barrier Transport Characteristics: In vivo Analysis using Brain Microdialysis in Cynomolgus Monkeys
Article
作者: Fujita, Takuya ; Tajima, Yoriko ; Ogihara, Takuo ; Kamikozawa, Yukari ; Miyamoto, Rei ; Watanabe, Daisuke ; Bessho, Koji ; Katagiri, Yuki ; Kusuhara, Hiroyuki ; Ozawa, Makoto ; Kurosawa, Toshiki ; Kakuuchi, Akito ; Taguchi, Takayuki ; Wakayama, Kentaro ; Deguchi, Yoshiharu ; Nagai, Mika ; Kawaguchi, Hiroko
OBJECTIVE:
The purpose of this study is to analyze the impact of the blood-brain barrier (BBB) and blood-cerebrospinal fluid barrier (BCSFB) transport characteristics of drugs on their intracerebral distribution in male cynomolgus monkeys.
METHODS:
Steady-state concentrations of 15 drugs (13 drugs and 2 compounds) transported by passive diffusion or via solute carrier (SLC) and/or ATP-binding cassette (ABC) transporters were measured in the frontal cortex interstitial fluid (ISF), lateral ventricular cerebrospinal fluid (CSF) and lumbar CSF of monkey brain by means of microdialysis and lumbar puncture methods. The values of brain ISF (or CSF)/plasma unbound concentration ratio (Kp,uu) were calculated to quantify the intracerebral distribution characteristics.
RESULTS:
The Kp,uu,ISF,cortex values of substrates of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP)were much lower than unity. The ISF concentration of these drugs were increased by the co-administration of elacridar, suggesting active efflux of these drugs at the BBB. Contrary to expectations, some of P-gp substrates were efficiently distributed into the brain with Kp,uu,ISF,cortex > 2. The lateral ventricular CSF concentrations of drugs tended to be higher than the ISF concentrations, while the lumbar CSF concentrations were comparable to the ISF concentrations.
CONCLUSION:
The results of this study suggest that the intracerebral distribution of the test drugs from the blood in the monkey brain should consider the contribution of influx transporters as well as efflux transporters. In addition, the lumbar CSF concentrations of the test drugs appear to be a useful surrogate marker of the ISF concentrations.
2025-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-utility analysis of isavuconazole compared with the standard of care as a first-line therapy for patients with invasive fungal infection prior to differential pathogen diagnosis in Japan
Article
作者: Inoue, Shun ; Igarashi, Ataru ; Onishi, Yasushi
AIMS:
This study aimed to evaluate the cost-effectiveness of isavuconazole compared with voriconazole as a first-line therapy for patients with invasive aspergillosis prior to differential pathogen diagnosis.
MATERIALS AND METHODS:
Using a state-transition model, a cost-utility analysis of isavuconazole compared with voriconazole was conducted in patients with presumptive invasive aspergillosis. The study population consisted of patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT) or chemotherapy who developed invasive fungal infections. The incremental cost-effectiveness ratio (ICER) was analyzed from the perspective of public healthcare. In patients with presumptive invasive aspergillosis, 6.6% were assumed to have mucormycosis. Efficacy data were sourced from the SECURE and VITAL trials, which included patients with invasive aspergillosis and mucormycosis. Expected survival was based on data for acute myeloid leukemia. The cost of voriconazole was based on its generic price. Different parameters were set for quality of life, expected survival period, and hospitalization costs in the HSCT and chemotherapy models, and the robustness of the model was evaluated using probabilistic and deterministic sensitivity analyses.
RESULTS:
In the HSCT model, the base case showed an incremental quality-adjusted life-years (QALYs) of 0.37 and an incremental cost of JPY 918,682 for isavuconazole compared with voriconazole, with an ICER of JPY 2,515,813. In the chemotherapy model, the incremental QALYs was 0.16, and the incremental cost was JPY 723,111, with an ICER of JPY 4,411,564. The probability sensitivity analysis showed that the proportion of ICERs below JPY 5 million was 100.0% in the HSCT model and 79.1% in the chemotherapy model.
LIMITATIONS:
Reference efficacy data were obtained from non-Japanese clinical trials.
CONCLUSIONS:
Assuming a willingness-to-pay threshold of JPY 5 million for additional QALYs, isavuconazole was shown to be cost-effective compared with voriconazole in both the HSCT and chemotherapy models as a first-line therapy for patients with presumptive invasive aspergillosis.
2025-11-01BIOTECHNOLOGY AND BIOENGINEERING
Development of a Small‐Scale Continuous Virus Filtration Model That Incorporates Inline Spiking and Mixing
Article
作者: Pintescu, Ioana ; Kozaili, Julie ; Strauss, Daniel
ABSTRACT:
Recent efforts have focused on shifting biomanufacturing from traditional batch mode processing to continuous processing as these technologies have the potential to increase productivity and product quality. However, the lack of a unified methodology for viral clearance validation of virus filtration (VF) in continuous processing has presented a hurdle to its implementation. Through the use of spiking a concentrated virus stock into a continuous filtration system, product flow with a stable virus level can be supplied to the filter over a long duration to allow uninterrupted flow and achieve viral clearance validation conditions comparable to those of traditional batch spiking for batch processing. In this study, we developed a small‐scale inline virus spiking and mixing model as a proposed validation strategy for a connected, continuous chromatography and VF system operated in constant flow mode over long durations and with high throughputs. The small‐scale model was successfully operated for upwards of 72 h and produced the expected virus‐spiked product feed solutions with no deviation in virus, protein and buffer concentrations throughout the runs. In addition, laboratory‐scale Planova BioEX filters showed complete removal of porcine parvovirus with a logarithmic reduction value greater than 5.5 when run continuously for 72 h.
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