Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 3:04 AM
Study NCT ID:
NCT06671405
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Open-label Study in Healthy Participants to Assess the Pharmacokinetics of AZD0780 When Administered Alone and in Combination With Itraconazole or Carbamazepine, and to Assess the Pharmacokinetics of Midazolam, and Ethinyl Estradiol/Levonorgestrel When Administered Alone and in Combination With AZD0780
Status:
COMPLETED
Status Verified Date:
2025-04
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:
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in combination with AZD0780.
Detailed Description:
The purpose of this study is to quantify the effect of itraconazole, a strong CYP3A inhibitor, and carbamazepine, a strong CYP3A inducer, on the PK of AZD0780 in healthy participants. This study will also evaluate AZD0780 as a precipitant of CYP3A4 mediated DDI by examining the PK of midazolam (a CYP3A4 substrate) and EE and LNG (CYP3A4 substrates) alone and in combination with AZD0780 in healthy participants.
The study duration (including screening period) will be approximately 9 to 10 weeks for Part 1, 12 to 14 weeks for Part 2, 6 to 8 weeks for Part 3, and 8 to 10 weeks for Part 4 (optional).
Study visits and treatment:
* Part 1: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 24 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 2: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 37 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 3: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 12 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 4 (optional): Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 22 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
Number of Participants:
Approximately 78 participants will be enrolled in this study; 18 participants in Part 1 (itraconazole Cohort), 24 participants in Part 2 (carbamazepine Cohort), 18 participants in Part 3 (midazolam Cohort), and 18 Participants in Part 4 (EE and LNG Cohort) (optional).
The study duration (including screening period) will be approximately 9 to 10 weeks for Part 1, 12 to 14 weeks for Part 2, 6 to 8 weeks for Part 3, and 8 to 10 weeks for Part 4 (optional).
Study visits and treatment:
* Part 1: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 24 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 2: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 37 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 3: Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 12 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
* Part 4 (optional): Participants who are eligible to participate in this study will stay at the Clinical Unit from Day -1 to Day 22 and return to the Clinical Unit again for a Follow-up Visit, 7 to 14 days after the last PK sample.
Number of Participants:
Approximately 78 participants will be enrolled in this study; 18 participants in Part 1 (itraconazole Cohort), 24 participants in Part 2 (carbamazepine Cohort), 18 participants in Part 3 (midazolam Cohort), and 18 Participants in Part 4 (EE and LNG Cohort) (optional).
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?: