Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547164
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant AZD9833 and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label 2 Part Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant AZD9833 on the Pharmacokinetics of Midazolam Exposure CYP3A45 Substrate and of Carbamazepine CYP3A45 Inducer on Camizestrant Exposure in Healthy Post Menopausal Female Participants
Status:
RECRUITING
Status Verified Date:
2024-10
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 conducted in order to determine the effect of repeated oral doses of camizestrant on the pharmacokinetics PK of midazolam and to determine the effect of repeated oral titrated doses of carbamazepine on the PK of camizestrant in healthy post-menopausal female participants
Detailed Description:
This is an open-label fixed sequence 2-part Part A and Part B drug-drug interaction study in healthy post-menopausal female participants
Part A of the study will assess the effect of repeated oral doses of camizestrant on the PK of a single oral dose of midazolam It will comprise
A Screening Period of maximum 28 days
Three Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until after the last camizestrant PK sample on Day 8
1 Period 1 participants will receive a single oral dose of midazolam Day 1
2 Period 2 participants will receive an oral once daily OD dose of camizestrant Day 2 to Day 6
3 Period 3 participants will receive a single oral dose of midazolam and camizestrant Day 7
A Follow-up Visit for which the participant will return to the Clinical Unit 7 2 days after the last camizestrant PK sample in Period 3
Part B of the study will assess the effect of multiple oral doses of carbamazepine on the PK of a single oral dose of camizestrant It will comprise
A Screening Period of maximum 28 days
Two Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until after the last camizestrant PK sample on Day 25
1 Period 1 participants will receive a single oral dose of camizestrant Day 1 with PK sampling on Day 1 to Day 4
2 Period 2 participants will receive low oral doses Dose 1 of carbamazepine twice a day BID on Day 4 to Day 6 mid oral doses Dose 2 of carbamazepine BID on Day 7 to Day 9 and high oral doses Dose 3 of carbamazepine BID on Day 10 to Day 24 On Day 22 participants will receive a single oral dose of camizestrant
A Follow-up Visit for which the participant will return to the Clinical Unit 7 2 days after the last camizestrant PK sample in Period 2
Part A of the study will assess the effect of repeated oral doses of camizestrant on the PK of a single oral dose of midazolam It will comprise
A Screening Period of maximum 28 days
Three Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until after the last camizestrant PK sample on Day 8
1 Period 1 participants will receive a single oral dose of midazolam Day 1
2 Period 2 participants will receive an oral once daily OD dose of camizestrant Day 2 to Day 6
3 Period 3 participants will receive a single oral dose of midazolam and camizestrant Day 7
A Follow-up Visit for which the participant will return to the Clinical Unit 7 2 days after the last camizestrant PK sample in Period 3
Part B of the study will assess the effect of multiple oral doses of carbamazepine on the PK of a single oral dose of camizestrant It will comprise
A Screening Period of maximum 28 days
Two Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration Day -1 until after the last camizestrant PK sample on Day 25
1 Period 1 participants will receive a single oral dose of camizestrant Day 1 with PK sampling on Day 1 to Day 4
2 Period 2 participants will receive low oral doses Dose 1 of carbamazepine twice a day BID on Day 4 to Day 6 mid oral doses Dose 2 of carbamazepine BID on Day 7 to Day 9 and high oral doses Dose 3 of carbamazepine BID on Day 10 to Day 24 On Day 22 participants will receive a single oral dose of camizestrant
A Follow-up Visit for which the participant will return to the Clinical Unit 7 2 days after the last camizestrant PK sample in Period 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None