Trials / Completed
CompletedNCT05406817
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Syndax Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 (\[14C\])-revumenib in participants with acute leukemia.
Detailed description
Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Revumenib | Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter. |
Timeline
- Start date
- 2022-08-05
- Primary completion
- 2024-11-18
- Completion
- 2024-11-18
- First posted
- 2022-06-07
- Last updated
- 2025-01-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05406817. Inclusion in this directory is not an endorsement.