Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT05443178

Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy

Led by University of Zurich · Updated on 2024-07-01

16

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In vitro and in vivo data show promising results of adjunctive use of Chloroquine to standard tuberculosis therapy as Chloroquine enhances animicrobial effectiveness against intracellular MTB. To date, no safety data of the concurrent use of both treatments is availble. In a phase I trial, the investigators aim to evaluate safety and tolerability of the concurrent use of Chloroquine and standard anti-TB drug in healthy volunteers.

CONDITIONS

Official Title

Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent for the study and possible genetic analysis
  • Healthy volunteers aged between 18 and 50 years
Not Eligible

You will not qualify if you...

  • Lack of highly effective contraception during treatment and for 8 months after last dose
  • Pregnant or lactating females
  • Known allergy or hypersensitivity to study drugs or glucose-6-phosphate dehydrogenase deficiency
  • Use of regular medications in the 14 days before study start except Paracetamol and Vitamin B6
  • History or presence of serious heart, immune, lung, nerve, kidney, digestive, skin, or hormone diseases
  • Any significant abnormalities in vital signs, ECG, labs, or medical/psychiatric conditions interfering with study
  • History or current retinal or vision problems
  • Alcohol or substance abuse in the last 3 months
  • Body weight less than 55 kg
  • Intake of grapefruit or grapefruit juice within 2 weeks before and during treatment
  • Blood donation within 30 days before screening
  • Current or planned participation in other interventional clinical trials within 3 months
  • Inability to follow study procedures due to language, psychological, or cognitive issues
  • Investigator or their close associates are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Trial Center

Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

K

Khadija M'Rabet, Dr. med.

CONTACT

J

Jean Marc Hoffmann, Dr med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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