Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04309656

A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid

Multi-drug Resistant Tuberculosis Clinical Trial

Official title:
An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid

Clinical Trial Summary

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.

Clinical Trial Description

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently. ;

Study Design

Related Conditions & MeSH terms

  • Multi-drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant
Clinical Trial Details
NCT number NCT04309656
Study type Interventional
Source Global Alliance for TB Drug Development
Contact
Status Completed
Phase Phase 1
Start date January 14, 2020
Completion date February 28, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03057756 - Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
Recruiting NCT04207112 - Economic Evaluation of New MDR TB Regimens Phase 2/Phase 3
Completed NCT03000517 - PK of Levofloxacin in MDR-TB Patients N/A
Completed NCT03470233 - Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Completed NCT03830671 - The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB Phase 4
Withdrawn NCT01600963 - A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis Phase 3
Recruiting NCT03575299 - Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells Phase 1
Recruiting NCT03827811 - Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
Completed NCT04342598 - Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
Completed NCT03822156 - Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
Completed NCT00425113 - Metronidazole for Pulmonary Tuberculosis (South Korea) Phase 2
Active, not recruiting NCT04081077 - PRACTECAL-PKPD Sub Study Phase 2/Phase 3
Recruiting NCT04397536 - New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
Completed NCT00691392 - Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) Phase 1/Phase 2
Completed NCT00664313 - TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB Phase 1/Phase 2