Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494644
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Open-label Single-group Three-period Fixed-sequence Phase I Study to Assess the Pharmacokinetics of AZD6793 Tablets When Administered Alone and in Combination With Itraconazole Capsules in Healthy Adult Female and Male Participants
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The study will evaluate the pharmacokinetics PK of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants
Detailed Description:
This is a single-group study with a duration of up to 8 weeks maximum of 53 days including Screening Period 1 Period 2 Period 3 and Follow-up
The study will comprise of
A screening period of 27 days
Three treatment periods Period 1 Day -1 to Day 3 Single dose AZD6793 will be administered on Day 1 followed by a 3-day washout period Period 2 Day 4 to Day 7 Itraconazole will be administered from Day 4 through Day 7 starting with 2 doses of 200 mg itraconazole given 12 hours apart on Day 4 then 200 mg itraconazole will be given once a day on Day 5 through Day 7 Period 3 Day 8 to Day 11 On Day 8 participants will be co-administered with AZD6793 and 200 mg itraconazole Administration of 200 mg itraconazole will continue on Day 9 and Day 10 Participants will be discharged from the clinic on Day 11
A Follow-up Visit 10-15 days after the last itraconazole dose in Period 3
The study will comprise of
A screening period of 27 days
Three treatment periods Period 1 Day -1 to Day 3 Single dose AZD6793 will be administered on Day 1 followed by a 3-day washout period Period 2 Day 4 to Day 7 Itraconazole will be administered from Day 4 through Day 7 starting with 2 doses of 200 mg itraconazole given 12 hours apart on Day 4 then 200 mg itraconazole will be given once a day on Day 5 through Day 7 Period 3 Day 8 to Day 11 On Day 8 participants will be co-administered with AZD6793 and 200 mg itraconazole Administration of 200 mg itraconazole will continue on Day 9 and Day 10 Participants will be discharged from the clinic on Day 11
A Follow-up Visit 10-15 days after the last itraconazole dose in Period 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509002-30-00 | OTHER | None | None |