Clinical Trial: Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer (Japan)

Tokyo, June 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061930) titled 'Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer' on June 16.

Study Type: Observational

Primary Sponsor: Institute - Shinshu University

Condition: Condition - Insomnia in patients with cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The aim of this study is to explore the interindividual variability in pharmacokinetics, clinical effects on sleep-related symptoms, and tolerability of orexin receptor antagonists in patients with cancer, focusing on cancer cachexia, inflammatory cytokines, CYP3A activity, genetic polymorphisms, and concomitant medications. Basic objectives2 - Pharmacokinetics

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 years or older with a confirmed diagnosis of solid cancer 2. Patients treated with orexin receptor antagonists 3. Patients treated in the outpatient or inpatient setting at Shinshu University Hospital 4. Patients from whom written informed consent was obtained Key exclusion criteria - 1. Patients using orexin receptor antagonists on an as-needed basis 2. Patients considered not to have reached steady-state plasma concentrations of orexin receptor antagonists 3. Patients who have undergone hematopoietic stem cell transplantation 4. Patients judged by the principal investigator to be inappropriate for the study Target Size - 200

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2022 Year 07 Month 29 Day Date of IRB - 2022 Year 09 Month 01 Day Anticipated trial start date - 2022 Year 09 Month 10 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070853

Disclaimer: Curated by HT Syndication.