NCT01856634

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.

Detailed description

This trial will investigate the pharmacokinetics (PK) and safety of delamanid administered 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 based on patient's body weight, n=12) * Patients \> 10 kg will receive 10 mg BID * Patients \> 8 kg and ≤ 10 kg will receive 5 mg BID * Patient ≤ to 8 kg will receive 5 mg QD

Conditions

• Multidrug Resistant Tuberculosis
• Pediatric

Interventions

Type	Name	Description
DRUG	100 mg Delamanid	100 mg Delamanid BID for 10 days
DRUG	50 mg Delamanid	50 mg Delamanid BID for 10 days
DRUG	25 mg Pediatric Formulation Delamanid	25 mg Pediatric Formulation Delamanid BID for 10 days
DRUG	10 mg Delamanid Pediatric Formulation	Patients \> 10 kg will receive DPF 10 mg BID for 10 days
DRUG	5 mg Delamanid Pediatric Formulation	Patients \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days
DRUG	Optimized Background Regimen	Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Timeline

• Start date: 2013-06-14
• Primary completion: 2017-12-10
• Completion: 2017-12-28
• First posted: 2013-05-17
• Last updated: 2018-01-30

Locations

2 sites across 2 countries: Philippines, South Africa