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Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

NCT05860114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-01-24

Study results available
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Summary

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.

Conditions

  • Drug Drug Interaction

Interventions

DRUG

Givinostat

Drug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension On days 1 and 13 givinostat was administered in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. Moreover the subjects were in a semi-recumbent position and remained semi-recumbent until at least 4 hours post-dose.No fluids were allowed from 1 hour before dosing until 2 hours post-dose. Water was provided ad libitum at all other times. From Day 5 to Day 12, subjects received givinostat 50 mg as oral suspension, twice a day, in the morning and in the evening.

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Marlene Fonseca, MD · Blueclinical, Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2022-05-08
Completion
2022-05-24
FDA Drug
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05860114 on ClinicalTrials.gov