Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256510
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-02-05
Brief Title:
A Study to Learn If the Study Medicine Called Vepdegestrant Changes How the Body Processes the Other Study Medicine Called Midazolam
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL PHASE 1 OPEN-LABEL FIXED SEQUENCE 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF SINGLE AND MULTIPLE DOSES OF VEPDEGESTRANT ARV-471 PF-07850327 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM IN HEALTHY ADULT FEMALES OF NON-CHILDBEARING POTENTIAL
Status:
COMPLETED
Status Verified Date:
2024-05
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 purpose of this study is to learn if the study medicine called Vepdegestrant changes how the body processes the other study medicine called Midazolam
This study is seeking participants who
female who cannot have children
are 18 years or older
are overtly healthy as decided by medical tests
have a body mass index BMI of 16 to 32 kilogram per meter squared
have a total body weight of more than 45 kilograms 99 pounds
All participants in this study will receive one dose of midazolam alone by mouth in Period 1 In Period 2 all participants will receive vepdegestrant by mouth once a day for 15 days Participants will also receive one dose of midazolam by mouth on day 1 and day 15
The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults
The study duration is 22 days and includes two periods Participants will stay in the clinical research unit through the end of period 2 A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time
This study is seeking participants who
female who cannot have children
are 18 years or older
are overtly healthy as decided by medical tests
have a body mass index BMI of 16 to 32 kilogram per meter squared
have a total body weight of more than 45 kilograms 99 pounds
All participants in this study will receive one dose of midazolam alone by mouth in Period 1 In Period 2 all participants will receive vepdegestrant by mouth once a day for 15 days Participants will also receive one dose of midazolam by mouth on day 1 and day 15
The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults
The study duration is 22 days and includes two periods Participants will stay in the clinical research unit through the end of period 2 A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-508518-40-00 | REGISTRY | EU CTIS | None |