An exploratory iNvestigation of rEal-World pharmacokinetics and TherApeutic drug monitoring-Guided personalized dosing of novel molEcular Targeted drugs

JRCT ID: jRCT1011240022

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neoplasms (Lung Cancer etc.), Inflammatory Bowel Diseases, Rheumatoid Arthritis, Autoimmune Diseases
• Date of first enrollment: 05/07/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: The variability of pharmacokinetics

Secondary Outcome

-Pharmacokinetic linearity across doses administered
-The incidence of adverse events
-Response to treatment (clinical response and clinical remission)
-Treatment persistence rate
-Exposure-safety relationship
-Exposure-efficacy relationship

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Subjects whose medical care and prognostic information can be obtained from medical records

Exclude criteria

Subjects presenting with any of the following will be excluded from the study:
1. Subjects who requested non-participation in this study based on a published opt-out document.
2. Subjects who are participating in or interested in participating in other clinical trials during the study period.

Related Information

• Primary Sponsor: Masahide Fukudo