Clinical Trial: NCT07454863
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Dizal Pharmaceuticals |
| Information Provided By: | Dizal Pharmaceuticals |
| Last Update Posted: | 2026-05-14 |
Study Overview
Brief 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.
Official Title
A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants
Conditions
Lymphoma, Non-Hodgkin
Intervention / Treatment
- Drug: DZD8586
Other Study ID Numbers
- DZ2025B0003
Start Date (Actual)
2026-03-16
Primary Completion Date (Actual)
2026-03-27
Study Completion Date (Actual)
2026-04-06
Enrollment (Actual)
6
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Dizal Pharmaceuticals |
| Information Provided By: | Dizal Pharmaceuticals |
| Last Update Posted: | 2026-05-14 |
Study Overview
Brief 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.
Official Title
A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants
Conditions
Lymphoma, Non-Hodgkin
Intervention / Treatment
- Drug: DZD8586
Other Study ID Numbers
- DZ2025B0003
Start Date (Actual)
2026-03-16
Primary Completion Date (Actual)
2026-03-27
Study Completion Date (Actual)
2026-04-06
Enrollment (Actual)
6
Study Type
Interventional
Phase
Phase 1