Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734275
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2021-01-28
Brief Title:
Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomised Single-dose Open-label Single-centre Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Fasted and Fed State in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a randomised open-label 3-period 3-treatment single-dose crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom
Detailed Description:
The study will comprise
A screening period of maximum 28 days
3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 Day -1 until at least 48 hours after dosing Day 3 with discharge on the morning of Day 3 of each treatment period and
A final visit within 5 to 7 days after the last administration of AZD5718
Subjects will receive single doses of AZD5718 on 3 occasions separated by at least 7 days washout under fasted and fed conditions Two different formulations Test Formulation and Reference Formulation will be given in a randomised order
Treatment A Test Formulation AZD5718 Dose A fasted
Treatment B Test Formulation AZD5718 Dose A fed
Treatment C Reference Formulation AZD5718 Dose A fasted
A screening period of maximum 28 days
3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 Day -1 until at least 48 hours after dosing Day 3 with discharge on the morning of Day 3 of each treatment period and
A final visit within 5 to 7 days after the last administration of AZD5718
Subjects will receive single doses of AZD5718 on 3 occasions separated by at least 7 days washout under fasted and fed conditions Two different formulations Test Formulation and Reference Formulation will be given in a randomised order
Treatment A Test Formulation AZD5718 Dose A fasted
Treatment B Test Formulation AZD5718 Dose A fed
Treatment C Reference Formulation AZD5718 Dose A fasted
Study Oversight
Has Oversight DMC:
None
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?:
None