A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
← catalyst calendarSponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Basic science
Enrollment
31actual
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-14 | actual | When the study began enrolling |
| Primary completion | 2026-02-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-06 | actual | The whole study's end, after follow-up |
| First posted | 2025-04-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hepatic Impairment
- Healthy
Interventions
- Drug: Palovarotene
- Drug: Palovarotene
- Drug: Palovarotene
Primary outcomes
what the primary-completion date above is the date OFMaximum observed plasma drug concentration (Cmax)
measured Over 96 hours postdose
Unbound fraction of drug in plasma (fu)
measured Over 96 hours postdose
Time to maximum observed plasma concentration (Tmax)
measured Over 96 hours postdose
Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUC0-∞)
measured Over 96 hours postdose
AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast)
measured Over 96 hours postdose
Apparent terminal elimination half life (T1/2)
measured Over 96 hours postdose
Apparent terminal elimination rate constant (λz).
measured Over 96 hours postdose
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