drugset / Trial / NCT07580833

A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors

NCT07580833

Phase 1 Not yet recruiting 46 enrolled Health Hope Pharma
RandomizedCrossoverOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about the effect of food on absorption of oral Paclitaxel when co- administered with Encequidar tablets in adult patients with tumours. The main questions it aims to answer are: * The effect of food and fasting on absorption of oral paclitaxel when combined with Encequidar tablets * Assessment of safety and tolerability of oral paclitaxel when combined with Encequidar tablets Participants will take Encequidar and oral paclitaxcel with a 1-hour space in between, either after an overnight fast of 10hours or after a meal three days in a row. After 10 days participants that received paclitaxel after fasting will receive the same medicine in the same way after a meal and vice versa. Some participants can elect to take part in the third part of the study which involves taking both paclitaxel and encequidar at the same time after a meal. Participants will \- For parts 1,2 and 3 participants will stay at the clinic from the day before the study starts until day 4 to receive the medicine and participate in checkups and tests. Participants will then visit the clinic on day 6 and 8 for further checkups and tests

Timeline

Start
2026-05
Primary completion
2026-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject HM30181AK Unknown Oral
Subject Paclitaxel Small molecule Oral

Indications