Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 12:25 AM
Study NCT ID:
NCT05845567
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
Sponsor:
Italfarmaco
Organization:
Study Overview
Official Title:
An Open-label, Single-center, Study in Healthy Subjects to Investigate the Effect of Oral Clarithromycin on the Pharmacokinetics of Givinostat (PART 2)
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-005756-11 | EUDRACT_NUMBER | None | View |