drugset / Trial / NCT02906007
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
Phase 1/2
Completed
54 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed rifampin-resistant tuberculosis (RR-TB). The study was designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks.
Timeline
- Start
- 2017-09-21
- Primary completion
- 2024-02-07
- Completion
- 2025-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 50 mg | — |
| Subject | Bedaquiline | Small molecule | 100 mg | — |
| Subject | Bedaquiline | Small molecule | 200 mg | — |