Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer

Study on interindividual variability in pharmacokinetics, pharmacodynamics and tolerability of orexin receptor antagonists in patients with cancer - Orexin receptor antagonist PK-PD and tolerability in patients with cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061930

Enrollment

200

Registered

2026-06-16

Start date

2022-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia in patients with cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of orexin receptor antagonists on day 7 or later after initiation of treatment	—

Secondary

Measure	Time frame
1. Sleep-related symptoms, including nocturnal awakenings and daytime sleepiness 2. Genotyping, including CYP3A5 3. CYP3A activity marker, including 4beta-hydroxycholesterol 4. Cancer cachexia status assessed by EPCRC classification and Glasgow Prognostic Score 5. Inflammatory cytokines and inflammatory/nutritional markers, including IL-6, CRP, albumin, and total cholesterol 6. Effects of concomitant medications 7. Adverse reactions, including somnolence, dizziness, falls, and other clinically relevant symptoms	—

Measure

Time frame

1. Sleep-related symptoms, including nocturnal awakenings and daytime sleepiness 2. Genotyping, including CYP3A5 3. CYP3A activity marker, including 4beta-hydroxycholesterol 4. Cancer cachexia status assessed by EPCRC classification and Glasgow Prognostic Score 5. Inflammatory cytokines and inflammatory/nutritional markers, including IL-6, CRP, albumin, and total cholesterol 6. Effects of concomitant medications 7. Adverse reactions, including somnolence, dizziness, falls, and other clinically relevant symptoms

—

Countries

Japan

Contacts

Public ContactSusumu Sakaue

Shinshu University Hospital Department of Pharmacy

sakaue@shinshu-u.ac.jp0263373022

Outcome results