Safety and tolerability of chloroquine in combination with a standard drug for tuberculosis in healthy volunteers

Switzerland (ICTRP)

ICTRP Trial ID
NCT05443178 (ICTRP)

Official title (approved by ethics committee)
OPEN LABEL, SINGLE CENTER, PHASE I DOSE ESCALATION AND EXTENSION TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF CHLOROQUINE AS ADJUVANT DRUG TO STANDARD 4-DRUG ANTI-TUBERCULOSIS THERAPY IN HEALTHY VOLUNTEERS (BASEC)

Academic title
Open Label, Single Center, Phase 1 Dose Escalation and Extension Trial to Evaluate Safety and Tolerability of Chlorquine as Adjuvant Drug to Standard 4-drug Anti-tuberculosis Therapy in Healthy Volunteers (ICTRP)

Public title
Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy (ICTRP)

Disease under investigation
Tuberculosis Infection (ICTRP)

Intervention under investigation
Drug: Nivaquine ? (Chloroquine) (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
Gender: All
Maximum age: 50 Years
Minimum age: 18 Years
Inclusion criteria:

1. Informed study-specific consent (including possible pharmacogenetic analysis) as
documented by signature

2. Healthy volunteers aged between 18 and 50 years of age (significantly increased risk
of side effects from 50 years of age with Rimstar?)

Exclusion criteria:

1. Lack of highly effective contraception during the study treatment and for 8 months
after the last dose of study treatment (until Day 254, visit 7) according to 11.4
with the following consideration for participating women:

- From Day 1 (visit 2) up to Day 30 (visit 6) hormonal contraception is
insufficient due to lower concentrations of estrogen and/or gestagen during and
up to 14 days after Rimstar? intake. The hormonal contraception must be
supplemented with a barrier method (preferably male condom).

- From Day 30 (visit 6) up to Day 254 (visit 7) hormonal contraceptive methods
can be used and are considered highly effective.

2. Pregnant or lactating females

3. Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product, glucose-6-phosphate
dehydrogenase insufficiency (favism)

4. Regular treatment with drugs in the last 14 days prior to first intake of study drug
(except for Paracetamol and Vitamin B6 (pyridoxine), see 8.7).

5. History of or concurrent, clinically significant cardiac, immunological, pulmonary,
neurological, renal, gastrointestinal, dermatological, endocrinological or other
major disease as determined by the Investigator and/or his representative

6. History of or presence of any clinically significant abnormality in vital signs,
ECG, or laboratory test results or has any medical or psychiatric condition that, in
the opinion of the Investigator, may interfere with the study procedures or
compromise subject safety

7. History of or currently present retinopathy or other disturbances of the field of
vision or the retina according to the Investigator

8. History of alcohol or substance abuse for the last 3 months prior to Screening, as
determined by the Investigator

9. Weight less than 55kg

10. Intake of grapefruit juice or grapefruits within 2 weeks before the first study drug
administration and during treatment phase

11. Donation of blood or blood products within a 30-day period prior to Screening

12. Current enrolment or a plan to enroll in any interventional clinical study in which
an investigational treatment or approved therapy for investigational use is
administered within 3 months of participation to the Clear trial.

13. Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant

14. The investigator, his/her family members, employees and other dependent persons (ICTRP)

not available

Primary and secondary end points
Physicial examination 1.1;Physicial examination 1.2;Physicial examination 2.1;Physicial examination 2.2;Physicial examination 3.1;Physicial examination 3.2;Physicial examination 4.1;Physicial examination 4.2;Physicial examination 5.1;Physicial examination 5.2;Physicial examination 6.1;Physicial examination 6.2;Vital Signs 1.1;Vital Signs 1.2;Vital Signs 1.3;Vital Signs 1.4;Vital Signs 1.5;Vital Signs 2.1;Vital Signs 2.2;Vital Signs 2.3;Vital Signs 2.4;Vital Signs 2.5;Vital Signs 3.1;Vital Signs 3.2;Vital Signs 3.3;Vital Signs 3.4;Vital Signs 3.5;Safety Laboratory samples Panel 1.1;Safety Laboratory samples Panel 1.2;Safety Laboratory samples Panel 1.3;Safety Laboratory samples Panel 1.4;Safety Laboratory samples Panel 2.1;Safety Laboratory samples Panel 2.2;Safety Laboratory samples Panel 2.3;Safety Laboratory samples Panel 2.4;Safety Laboratory samples Panel 3.1;Safety Laboratory samples Panel 3.2;Safety Laboratory samples Panel 3.3;Safety Laboratory samples Panel 3.4;Safety Laboratory samples Panel 4.1;Safety Laboratory samples Panel 4.2;Safety Laboratory samples Panel 4.3;Safety Laboratory samples Panel 4.4;Safety Laboratory samples Panel 5.1;Safety Laboratory samples Panel 5.2;Safety Laboratory samples Panel 5.3;Safety Laboratory samples Panel 5.4;Safety Laboratory samples Panel 6.1;Safety Laboratory samples Panel 6.2;Safety Laboratory samples Panel 6.3;Safety Laboratory samples Panel 6.4;Safety Laboratory samples Panel 7.1;Safety Laboratory samples Panel 7.2;Safety Laboratory samples Panel 7.3;Safety Laboratory samples Panel 7.4;Safety Laboratory samples Panel 8.1;Safety Laboratory samples Panel 8.2;Safety Laboratory samples Panel 8.3;Safety Laboratory samples Panel 8.4;Safety Laboratory samples Panel 9.1;Safety Laboratory samples Panel 9.2;Safety Laboratory samples Panel 9.3;Safety Laboratory samples Panel 9.4;Safety Laboratory samples Panel 10.1;Safety Laboratory samples Panel 10.2;Safety Laboratory samples Panel 10.3;Safety Laboratory samples Panel 10.4;Safety Laboratory samples Panel 11.1;Safety Laboratory samples Panel 11.2;Safety Laboratory samples Panel 11.3;Safety Laboratory samples Panel 11.4;Safety Laboratory samples Panel 12.1;Safety Laboratory samples Panel 12.2;Urinanalysis 1.1;Urinanalysis 1.2;Urinanalysis 1.3;Urinanalysis 1.4;Urinanalysis 2.1;Urinanalysis 2.2;Urinanalysis 2.3;Urinanalysis 2.4;Urinanalysis 3.1;Urinanalysis 3.2;Urinanalysis 3.3;Urinanalysis 3.4;Urinanalysis 4.1;Urinanalysis 4.2;Urinanalysis 4.3;Urinanalysis 4.4;Safety 12 lead ECG 1.1;Safety 12 lead ECG 1.2;Safety 12 lead ECG 2.1;Safety 12 lead ECG 2.2;Safety 12 lead ECG 3.1;Safety 12 lead ECG 3.3;Safety 12 lead ECG 4.1;Safety 12 lead ECG 4.2;Safety 12 lead ECG 5.1;Safety 12 lead ECG 5.2;Safety ophtalmological examination 1.1;Safety ophtalmological examination 1.2;Safety ophtalmological examination 1.3;Safety ophtalmological examination 1.4;Safety ophtalmological examination 1.5;Occurence of adverse events and serious adverse events 1.1;Occurence of adverse events and serious adverse events 1.2;Occurence of adverse events and serious adverse events 1.3;Occurence of adverse events and serious adverse events 1.4;Occurence of adverse events and serious adverse events 1.5;Occurence of adverse events and serious adverse events 1.6 (ICTRP)

Drug concentration over time measured by the pharmacokinetics (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Marisa Kaelin, Dr. med.;Khadija M'Rabet, Dr. med.;Khadija M'Rabet, Dr.med., Khadija.MRabet-Bensalah@usz.ch, +41 44 255 13 65;+41442551365, University of Zurich, (ICTRP)

Secondary trial IDs
Clear TB (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05443178 (ICTRP)