Drug Drug Interaction Clinical Trial
Official title:
An Open-label, Single-center, Study in Healthy Subjects to Evaluate the Plasma and Urine Pharmacokinetics of Givinostat and Its Metabolites Following Single and Multiple Oral Doses of Givinostat (Part 3).
Primary objective: To evaluate the plasma and urine PK of givinostat following multiple oral doses of givinostat. Secondary objective: To assess the safety and tolerability multiple oral doses of givinostat.
This study was planned as a phase I, open-label, 3-part, fixed-sequence, nonrandomized study in healthy male and female subjects. The study (Part 3) aimed at assessing Givinostat and its metabolites (ITF2374, ITF2375, ITF2440 and ITF2563) plasma and urine concentrations and thereof derived pharmacokinetic parameters following single oral dose administration of givinostat (day 1) and following multiple oral dose administration of givinostat (day 5 to day 13). More precisely, Gmean and corresponding 95% CI of givinostat plasma and urine concentration and givinostat metabolites plasma concentration versus time profiles following single (Day 1) and multiple-dose (Day 5 to Day 13) administration of givinostat are reported using Linear Scale and Semi- Logarithmic Scale. Descriptive statistics of givinostat plasma pharmacokinetic parameters and givinostat metabolites PK parameters following single-dose administration of givinostat (day 1) and following multiple-dose administration of givinostat (Day 13) were calculated. Descriptive statistics of givinostat and its metabolites urinary excretion profile following single-dose administration of givinostat (day 1) and following multipledose administration of givinostat (Day 13) were calculated. Descriptive statistics of givinostat and its metabolites cumulative amount of urinary excretion profile following single-dose administration of givinostat (day 1) and following multiple-dose administration of givinostat (Day 13) were also calculated using linear scales. ;
| 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 |
NCT05845567 -
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
|
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 |