Tuberculosis, Pulmonary Clinical Trial
Official title:
Safety, Tolerability and Pharmacokinetic Profile of PBTZ169 Formulated as Native Crystal Powder: Multiple Ascending Doses, Randomized, Placebo- Controlled, Parallel-group, Sequential Phase Ib Trial in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in Switzerland. Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each receiving multiple doses of PBTZ169 or a matching placebo, at increasing dose levels, once or twice daily. Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment, 1 under placebo) will be investigated in parallel. Panels will start sequentially. Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of PBTZ169. Dose escalation will be allowed once the Trial Safety Board has determined that adequate safety and tolerability after each panel completion has been demonstrated to permit proceeding to the next panel. In addition, a preliminary assessment of the drug interaction potential of PBTZ169 will be done by the measurement of inhibition or induction of human cytochromes through the metabolism of microdoses of standard probe substrates
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06084715 -
The INSTITUT Study
|
||
| Terminated |
NCT03028129 -
Prevention of Tuberculosis in Prisons
|
Phase 4 | |
| Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
| Withdrawn |
NCT03862248 -
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
|
Phase 3 | |
| Completed |
NCT03271567 -
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
|
||
| Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
| Recruiting |
NCT04919239 -
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
|
Phase 2 | |
| Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
| Recruiting |
NCT05926466 -
BTZ-043 Dose Evaluation in Combination and Selection
|
Phase 2 | |
| Recruiting |
NCT04752592 -
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
|
N/A | |
| Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
| Not yet recruiting |
NCT04968886 -
TuBerculosis Viability Interregional Study and Agreement on Biological Tests
|
||
| Not yet recruiting |
NCT04485156 -
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
|
Phase 3 | |
| Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
| Completed |
NCT01364324 -
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
|
||
| Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
| Completed |
NCT05899400 -
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
|
||
| Recruiting |
NCT04938596 -
Airborne Preventive Measures to Reduce New TB Infections in Household Contacts
|
N/A | |
| Recruiting |
NCT05455112 -
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
|
Phase 2 | |
| Completed |
NCT03044158 -
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
|
N/A |