German Clinical Trials Register

Sex:

All

1. Clinically significant or relevant abnormalities in the medical history, physical examination, and laboratory evaluation as assessed by the investigator, 2. Any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMPs or trial interventions, 3. Clinically relevant ongoing or clinically relevant history of physical or psychiatric illness as judged by the investigator, 4. Pregnancy or breast feeding, 5. Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of HCQ, midazolam, yohimbine, or pantoprazole, 6. Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies (except mild forms of hay fever), 7. Any known allergies to the compound or further ingredients of HCQ, quinine, pantoprazole, midazolam, or yohimbine preparations, 8. Prolonged QTc time: women: QTcF > 460 ms, men: QTcF > 440 MS 9. Clinically relevant findings at SCR. Minor deviations of laboratory values from the normal range can be acceptable, if judged by the investigator to be of no clinical relevance for this Trial 10. A positive human immunodeficiency virus and hepatitis C antibody screen, 11. A positive result in the drug screening test 12. Any intake of HCQ, chloroquine or travel to malaria risk regions within the last 3 months, 13. Use of any medication (prescription medication, non-prescription medication including multivitamin or herbal preparations) with active ingredients except hormonal contraception and thyroid hormones, or any intake of substances known to induce or inhibit HCQ-metabolizing enzymes or drug transporters within a period of less than 5 times the respective elimination half-life (t1/2) with regard to the expected date of the first dose of IMP, 14. Consumption of citrus fruits or products of these fruits within 7 d prior to the expected date of first dose of IMP and expected nonadherence to refrain from such products until V5, 15. Expected nonadherence to refrain from alcohol 24 h prior to V1 until V5 of this trial, or excessive alcohol consumption. 16. Intake of quinine, or consumption of quinine-containing drinks (bitter lemon, tonic water, bitter orange) 17. Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial. 18. Contraindications to HCQ use