Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-27 @ 5:04 PM
Study NCT ID:
NCT04187456
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Open Label, 2 Period, Fixed-sequence Study to Assess the Effect of Savolitinib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.
Detailed Description:
This study is designed as an open-label, 2 treatment period, fixed sequence study in healthy male subjects, performed at a single study center.
The study will comprise:
* A screening period of maximum 28 days;
* Two treatment periods:
Treatment Period 1 consists of 5 days (Study Days -1 to 4), starting with admission to the Study Center on Study Day -1, dosing of midazolam alone on Study Day 1 and ending on Study Day 4, after a 3 day washout period.
Treatment Period 2 consists of 2 days (Study Days 5 and 6), with administration of midazolam in combination with savolitinib on Study Day 5. Subjects will be discharged from the Study Center on Study Day 6, after the last PK sample is collected.
* The Follow up Visit will occur at least 14 days (Study Day 19 or after) after the administration of savolitinib in Treatment Period 2.
* Subjects will be admitted to the Study Center on Study Day -1, prior to the evening meal the night before dosing with midazolam alone (Study Day 1) and will stay in house until at least 24 hours after dosing with midazolam in combination with savolitinib (Study Day 5). Subjects will thus be discharged on Study Day 6, after the last PK sample has been collected.
Each subject will be involved in the study between 21 and approximately 48 days.
The study will comprise:
* A screening period of maximum 28 days;
* Two treatment periods:
Treatment Period 1 consists of 5 days (Study Days -1 to 4), starting with admission to the Study Center on Study Day -1, dosing of midazolam alone on Study Day 1 and ending on Study Day 4, after a 3 day washout period.
Treatment Period 2 consists of 2 days (Study Days 5 and 6), with administration of midazolam in combination with savolitinib on Study Day 5. Subjects will be discharged from the Study Center on Study Day 6, after the last PK sample is collected.
* The Follow up Visit will occur at least 14 days (Study Day 19 or after) after the administration of savolitinib in Treatment Period 2.
* Subjects will be admitted to the Study Center on Study Day -1, prior to the evening meal the night before dosing with midazolam alone (Study Day 1) and will stay in house until at least 24 hours after dosing with midazolam in combination with savolitinib (Study Day 5). Subjects will thus be discharged on Study Day 6, after the last PK sample has been collected.
Each subject will be involved in the study between 21 and approximately 48 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: