A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
NCT07454863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-05-14
Summary
This phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of \[14C\]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants. Participants will be administered a single oral dose of 50 mg of \[14C\]-DZD8586 (containing radioactive dose \~ 100 μCi) as a suspension.
Conditions
- Lymphoma, Non-Hodgkin
Interventions
- DRUG
-
DZD8586
Carbon-14 labeled DZD8586
Sponsors & Collaborators
-
Dizal Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Yiqing Zhao · Affiliated Hospital of Jiangnan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-16
- Primary Completion
- 2026-03-27
- Completion
- 2026-04-06
- FDA Drug
- Yes
Countries
- China
Study Locations
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