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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state.
The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state.
Research Site
Glendale, United Kingdom
Maximum observed plasma (peak) drug concentration (Cmax)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Time frame: Day 1 - 9
Area under plasma concentration time curve from zero to infinity (AUCinf)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Time frame: Day 1 - 9
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Time frame: Day 1 - 9
Cmax of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Time frame: Day 1-9
AUCinf of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Time frame: Day 1-9
AUClast of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Time frame: Day 1-9
Cmax of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Time frame: Day 1-6
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AUCinf of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Time frame: Day 1-6
AUClast of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Time frame: Day 1-6
Number of subject with Adverse event (AE) and serious Adverse event (SAE)
The safety and tolerability following single oral doses ofAZD5055 administered with nintedanib in healthy participants will be assessed.
Time frame: SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 untill follow up (Day 13)