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
The study is intended to quantify the effect of co-administration and staggered dosing of AZD5055 and nintedanib on exposures of nintedanib in healthy participants.
This study will be an open-label, randomised, crossover study in healthy participants (males and females of non-childbearing potential). The study will comprise two parts: Part A and Part B. The study will include a screening period of 28 days for both Part A and Part B. Part A will be a 3-period (Periods 1, 2, 3), 3-treatment (Treatments A, B, C) crossover study, performed at a single clinical unit. During the 3 periods (Periods 1, 2, 3) participants will participate from Day -1 of Period 1 to 72 hours after the nintedanib dose in Period 3. In each period, the participants will receive AZD5055 immediately before the nintedanib dose in the morning of the first day. In Part A, all participants will be randomised to one of 3 sequences. An interim analysis of data from Part A will be performed, and Part B (conducted only if an interaction between AZD5055 and nintedanib is observed in Part A) will be a 2-period (Periods 1, 2), 2-treatment (Treatments A, D) crossover study, performed at 2 clinical units. In each period, the participants in Treatment D will be dosed with AZD5055 4 hours after the nintedanib dose in the morning of the first day. In Part B, all participants will be randomised to one of 2 sequences. For both Part A and Part B, there will be a minimum washout period of approximately 72 hours between each AZD5055 dose administration. And, a follow-up visit will be performed, at 6 ± 1 days after the last dose of nintedanib in last period.
Location
Location
Glendale, United Kingdom, 91206
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. |
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