NCT05644600

A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.

An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-26
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2022-12-09
• Last updated: 2024-02-08

Locations

1 site across 1 country: United Kingdom