Trials / Not Yet Recruiting
Not Yet RecruitingNCT07454863
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Dizal Pharmaceuticals · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DZD8586 | Carbon-14 labeled DZD8586 |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-08-01
- Completion
- 2026-09-01
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07454863. Inclusion in this directory is not an endorsement.