Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Condition(s) studied
Investigational drug(s) / intervention(s)
pelabresib: pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break
Study summary
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.
Eligibility
Primary outcome measure(s)
- Area Under the Curve from 0 to 24 hours on Day 14 (AUC₀-24h,D14) of pelabresib at steady state per study group — Cycle 1 Day 14: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)
Venous whole blood samples will be collected for pharmacokinetics characterization. AUC₀-24h,D14 of pelabresib at steady state per study group will be listed and summarized using descriptive statistics. - Maximum Plasma Concentration on Day 14 (Cmax,D14) of pelabresib at steady state per study group — Cycle 1 Day 14 (1 cycle = 21 days)
Venous whole blood samples will be collected for pharmacokinetics characterization. Cmax,D14 of pelabresib at steady state per study group will be listed and summarized using descriptive statistics. - Apparent Clearance (CL/F) of pelabresib at steady state per study group — Cycle 1 Day 14 (1 cycle = 21 days)
Venous whole blood samples will be collected for pharmacokinetics characterization. CL/F of pelabresib at steady state per study group will be listed and summarized using descriptive statistics. - Apparent Volume of Distribution (V/F) of pelabresib at steady state per study group — Cycle 1 Day 14 (1 cycle = 21 days)
Venous whole blood samples will be collected for pharmacokinetics characterization. V/F of pelabresib at steady state per study group will be listed and summarized using descriptive statistics. - Terminal Half-Life (T½) of pelabresib at steady state per study group — Cycle 1 Day 14 (1 cycle = 21 days)
Venous whole blood samples will be collected for pharmacokinetics characterization. T½ of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Bordeaux | France | Recruiting |
| Novartis Investigative Site | Saint-Herblain | France | Recruiting |
| Novartis Investigative Site | Milan | MI | Recruiting |
| Novartis Investigative Site | Milan | MI | Recruiting |
| Novartis Investigative Site | Candiolo | TO | Recruiting |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | Recruiting |
| Novartis Investigative Site | Barcelona | Spain | Recruiting |
| Novartis Investigative Site | Madrid | Spain | Recruiting |
| Novartis Investigative Site | Madrid | Spain | Recruiting |
| Novartis Investigative Site | London | United Kingdom | Recruiting |
More Novartis Pharmaceuticals trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07422610 on ClinicalTrials.gov ↗ ← All trials in Spain