drugset / Trial / NCT04553406
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
Timeline
- Start
- 2020-12-03
- Primary completion
- 2021-01-28
- Completion
- 2021-01-28
Outcome
Outcome not reported
Stopped (Business): “Business decision pending resolution of clinical hold with FDA”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 250 mg | Oral |
| Comparator | Azithromycin | Small molecule | 500 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 1000 mg | Oral |
| Comparator | Ethambutol | Small molecule | 15 mg/kg | Oral |
| Comparator | Rifabutin | Small molecule | 300 mg | Oral |
| Comparator | Rifampicin | Small molecule | 600 mg | Oral |
| Subject | SPR720 | Small molecule | 500 mg | Oral |
| Subject | SPR720 | Small molecule | 1000 mg | Oral |