Clinical Trials Logo

Clinical Trial Summary

Primary objective: To assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of Givinostat. Secondary objective: To assess the safety and tolerability of concomitant administration of Givinostat plus Clarithromycin.


Clinical Trial Description

This study was planned as a phase I, open-label, 3-part, fixed-sequence, non-randomized study in healthy male and female subjects. The study (Part 2) aimed at assessing the potential effect of Clarythromycin on the single dose pharmacokynetics of Givinostat. The total duration of Part 2 was divided as follows: - Screening: up to 21 days. - Treatment Period: Days 1 to 11. - Safety follow-up visit: 12±2 days. Subjects were confined at site from Day -1 to Day 11. On Days 1 and 8, a single dose of 50 mg Givinostat, as oral suspension, was administered 1 hour after the planned morning time of Clarithromycin administration. From Day 4 to Day 10, clarithromycin 500 mg film-coated tablets were administered twice a day, in the morning and in the evening. The following assessments were performed: - Blood collection for pharmacokinetic analysis on Days 1 to 4 and 8 to 11. - Vital signs measurements on Days 1 and 4 to 10. - 12-lead ECG on Days 1, 3, 7 and 8. - Blood collection for laboratory tests (hematology and biochemistry) on Day 3. Subjects were discharged in the morning of Day 11 after completing end of study procedures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05845567
Study type Interventional
Source Italfarmaco
Contact
Status Completed
Phase Phase 1
Start date March 21, 2022
Completion date May 24, 2022

See also
  Status Clinical Trial Phase
Completed NCT05574374 - Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects Phase 1
Completed NCT04557397 - Fruquintinib CYP3A Inhibitor and Inducer Study Phase 1
Completed NCT06031454 - Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin Phase 1
Completed NCT05137600 - A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects Phase 1
Recruiting NCT06119958 - Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects Phase 1
Active, not recruiting NCT05812404 - Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects Phase 1
Completed NCT04606537 - Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects Phase 1
Completed NCT04939467 - Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers Phase 1
Completed NCT04542252 - Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects Phase 1
Enrolling by invitation NCT06037564 - B-free Multistage Trial Phase 4
Completed NCT05123820 - Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470 Phase 1
Recruiting NCT04840862 - Impact of Rifabutin on the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Phase 4
Completed NCT04814498 - Drug-Drug Interaction (DDI) Study in Healthy Volunteers Phase 1
Completed NCT01350921 - Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers Phase 1
Completed NCT03103568 - A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers Phase 1
Completed NCT04840641 - Flucloxacillin as an Inducer of CYP-enzymes Phase 1
Completed NCT05860114 - Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3) Phase 1
Completed NCT05304845 - Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects Phase 1
Completed NCT04776499 - Possible Effects of Propylthiouracil, Riociguat and Perphenazine on Circulation of Healthy Volunteers Phase 1
Completed NCT03909529 - Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug) Phase 1