drugset / Trial / NCT04044001

BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)

Phase 1/2 Completed 77 enrolled Michael Hoelscher European and Developing Countries Clinical Trials Partnership (EDCTP) · collab German Federal Ministry of Education and Research · collab Radboud University Medical Center · collab

RandomizedSequentialSingle-blindTreatment

Summary

This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once daily over 14 days to participants with newly diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis. The primary objective is to assess the safety and tolerability of BTZ-043 given over 14 days by evaluation of adverse events during treatment and follow-up period in patients with newly diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis.

Timeline

Start: 2019-11-15
Primary completion: 2022-03-03
Completion: 2022-05-31

Publications

Heinrich N, de Jager V, Dreisbach J, Gross-Demel P, Schultz S, Gerbach S, Kloss F, Dawson R, Narunsky K, Matt L, Wildner L, McHugh TD, Fuhr U, Aldana BH, Mouhdad C, Brake LT, Boeree MJ, Aarnoutse RE, Svensson EM, Gong X, P J Phillips P, Diacon AH, Hoelscher M; PanACEA-TB consortium. Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial. Lancet Microbe. 2025 Feb;6(2):100952. doi: 10.1016/j.lanmic.2024.07.015. Epub 2025 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BTZ-043	Small molecule	250 mg	Oral
Subject	BTZ-043	Small molecule	500 mg	Oral
Subject	BTZ-043	Small molecule	750 mg	Oral
Subject	BTZ-043	Small molecule	1000 mg	Oral
Subject	BTZ-043	Small molecule	1250 mg	Oral
Subject	BTZ-043	Small molecule	1500 mg	Oral
Subject	BTZ-043	Small molecule	1750 mg	Oral
Subject	BTZ-043	Small molecule	2000 mg	Oral
Subject	Caffeine	Small molecule	150 mg	Oral
Subject	Dextromethorphan	Unknown	30 mg	Oral
Subject	Digoxin	Other / unclassified	0.5 mg	Oral
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Ethambutol	Small molecule	825 mg	Oral
Subject	Ethambutol	Small molecule	1100 mg	Oral
Subject	Ethambutol	Small molecule	1375 mg	Oral
Subject	Isoniazid	Small molecule	225 mg	Oral
Subject	Isoniazid	Small molecule	300 mg	Oral
Subject	Isoniazid	Small molecule	375 mg	Oral
Subject	Midazolam	Small molecule	2 mg	Oral
Subject	Pyrazinamide	Small molecule	1200 mg	Oral
Subject	Pyrazinamide	Small molecule	1600 mg	Oral
Subject	Pyrazinamide	Small molecule	2000 mg	Oral
Subject	Rifampin	Small molecule	450 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral
Subject	Rifampin	Small molecule	750 mg	Oral
Subject	Tolbutamide	Small molecule	125 mg	Oral

BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)

Summary

Timeline

Publications

Drugs

Indications