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The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

NCT05845567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-16

Study results available
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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.

Conditions

  • Drug Drug Interaction

Interventions

DRUG

Givinostat

ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.

DRUG

Clarithromycin

Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered 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

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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 NCT05845567 on ClinicalTrials.gov