NCT06929260

A Study to Evaluate the Effect of Ceralasertib on Drug X, Drug Y and Drug Z

A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours.

Detailed description

This is an open-label, 3-period fixed-sequence study. The study will comprise of - * Screening Visit (Visit 1) * Period 1 (Visit 2) * Period 2 (Visit 3) * Period 3 (Visit 4) * Follow-up Visit (Visit 5) A wash-out period of no less than 48 hours in each period.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	Ceralasertib	Participants will receive repeated dosing of ceralasertib from Day 1 to Day 7 until steady state.
DRUG	Drug X	Participants will receive a single dose of Drug X on Day 5 and Day 22.
DRUG	Drug Y	Participants will receive a single dose of Drug Y on Day 7 and Day 28.
DRUG	Drug Z	Participants will receive a single dose of Drug Z on Day 7 and Day 28.

Timeline

• Start date: 2025-05-21
• Primary completion: 2025-10-15
• Completion: 2025-12-18
• First posted: 2025-04-16
• Last updated: 2026-01-22

Locations

1 site across 1 country: United Kingdom