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drugset / Trial / NCT04044001

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

NCT04044001 ↗

Phase 1/2 Completed 78 enrolled Michael Hoelscher European and Developing Countries Clinical Trials Partnership (EDCTP) · collabGerman Federal Ministry of Education and Research · collabRadboud 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

Drugs

EvaluationDrugModalityDoseRoute
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 Rifampicin Small molecule 450 mg Oral
Subject Rifampicin Small molecule 600 mg Oral
Subject Rifampicin Small molecule 750 mg Oral
Subject Tolbutamide Small molecule 125 mg Oral

Indications

pulmonary tuberculosis