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

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.

Conditions

• Pulmonary Tuberculoses
• Other 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.

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Radboud University Medical Center

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Michael Hoelscher

  lead OTHER

Principal Investigators

• Michael Hoelscher, Prof · University Hospital, LMU Munich, Division of Infectious Diseases and Tropical Medicine

• Andreas Diacon, Prof · TASK Applied Science Clinical Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-15

Primary Completion

2022-03-03

Completion

2022-05-31

Countries

• South Africa

Study Locations