NCT04044001 - BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 15, 2019

Primary Completion Date

March 3, 2022

Study Completion Date

May 31, 2022

Conditions

Pulmonary TuberculosesOther Specified Pulmonary Tuberculosis

Interventions

DRUG

BTZ-043

BTZ-043 (250mg per tablet)

DRUG

Rifafour e-275®

Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)

DRUG

Probe Drug Cocktail

"A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of~* Caffeine: 1 tablet à 150mg~* Tolbutamide: 1/4 tablet à 500mg~* Dextromethorphan: 10 ml syrup à 15mg/5ml~* Midazolam:2 ml solution à 5mg/5ml~* Digoxin: 2 tablets à 0.25mg"

DRUG

Dolutegravir 50mg Tab

1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.

Trial Locations (2)

7530

TASK Applied Sciences Clinical Research Centre, Cape Town

7700

University of Cape Town Lung Institute (UCTLI), Cape Town

All Listed Sponsors

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Radboud University Medical Center

OTHER

collaborator

German Federal Ministry of Education and Research

OTHER_GOV

lead

Michael Hoelscher

OTHER