Study identifier:D8960C00003
ClinicalTrials.gov identifier:NCT05644600
EudraCT identifier:2022-003116-84
CTIS identifier:N/A
An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.
Healthy subjects
Phase 1
Yes
Nintedanib, AZD5055
All
18
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment A The subjects will receive Nintedanib soft capsules, fasted state. | Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. |
Experimental: Treatment B The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. | Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state. |
Experimental: Treatment C The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. | Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state. |
Experimental: Treatment D The subjects will receive dose C of the oral suspension of AZD5055 4 hours after nintedanib in the fasted state. Participants would remain in the fasted state until 1.5 hours after AZD5055 administration. | Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state. |