At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Givinostat +1 moredrug
Likely dose
Givinostat 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single-center, Study in Healthy Subjects to Investigate the Effect of Oral Clarithromycin on the Pharmacokinetics of Givinostat (PART 2)
In Brief
A Phase 1 clinical trial evaluating Givinostat and Clarithromycin for Drug Drug Interaction. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Drug Interaction
CountriesPortugal
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartMar 2022
Primary CompletionMay 2022
Study CompletionMay 2022
First PostedMay 2023
TodayJul 2026
First PostedMay 6, 2023
Enrollment StartMar 21, 2022
Primary CompletionMay 8, 2022
Study CompletionMay 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.2 years ago
Interventions
Givinostatdrug
ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
Clarithromycindrug
Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered twice a day, in the morning and in the evening.