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A multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 given as an oral single 50 mg dose in participants with chronic hepatic impairment relative to matched participants with normal hepatic function.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513577-43-00
Acronym
ITF2357-60
Enrollment
24
Registered
2025-04-30
Start date
2025-05-16
Completion date
2025-08-14
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with mild HI, Participants with moderate HI, Participants with normal hepatic function

Interventions

None listed

Sponsors

Italfarmaco S.p.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Bulgaria, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026