A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine
NCT06021600 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2026-04-09
Summary
To compare an investigational oral form of the drug cladribine to the FDA approved form of the drug when it is given by vein (IV).
Conditions
Interventions
- DRUG
-
Cladribine
Given by PO and Given by IV (vein)
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Farhad Ravandi-Kashani, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-09
- Primary Completion
- 2026-03-24
- Completion
- 2026-03-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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