drugset / Trial / NCT03891901
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
Phase 2
Completed
24 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Aurum Institute · collabEmory University · collabUniversity of Florida · collabUniversity of Pennsylvania · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin. The results of this trial will determine the imatinib dose to be studied in a subsequent Phase IIB treatment trial of imatinib as an adjunctive therapy with an antimicrobial regimen (rifabutin, pyrazinamide (PZA), isoniazid (INH) and ethambutol) for drug-sensitive TB.
Timeline
- Start
- 2020-10-27
- Primary completion
- 2022-08-30
- Completion
- 2022-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 50 mg | Oral |
| Subject | Imatinib | Small molecule | 100 mg | Oral |
| Subject | Imatinib | Small molecule | 200 mg | Oral |
| Subject | Imatinib | Small molecule | 400 mg | Oral |
| Background | Isoniazid | Small molecule | 300 mg | Oral |
| Background | Rifabutin | Small molecule | 300 mg | Oral |