Phase 1 Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis (242-12-232)

Study Director
Start Date
5 / 2013
Trial Phase
Phase I
Trial Status
Current Enrollment
Target Enrollment


This trial investigates the pharmacokinetics (PK) and safety of delamanid administered twice daily for 10 days to pediatric patients aged birth to 17 years who are also on therapy with an optimized background regimen. The purpose of the trial is to determine which dose in pediatric MDR-TB patients will result in delamanid plasma exposure similar to efficacious plasma exposure in adult MDR-TB patients. This is an age de-escalation trial in four groups:

Group 1: 12 to 17 years (100 mg BID; n=6) Group 2: 6 to 11 years (50 mg BID; n =6) Group 3: 3 to 5 years (25 mg BID; n=12) Group 4: Birth to 2 years (dose to be determined; n=12)

Enrollment of patients for Groups 1 and 2 is complete. Dosing of patients in Group 4 will be determined after data from at least 6 subjects from Group 3 is available.

Compound Associations