Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645938
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE I RANDOMIZED OPEN-LABEL 2-PERIOD 2-TREATMENT 2-SEQUENCE CROSSOVER SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT HIGH HARDNESS TABLET OF VEPDEGESTRANT ARV-471 PF-07850327 RELATIVE TO THE REGISTRATIONAL TABLET
Status:
NOT_YET_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:
The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation
This study is seeking male or female participants of non-childbearing potential age who
are 18 years or older
are healthy as decided by medical tests
have a Body mass index BMI of 16 to 32 kilogram per meter squared and a total body weight of more than 45 kilograms 99 pounds
All participants will be put into groups to receive one of the 2 treatments in each period This study will consist of 2 treatment sequences
Sequence 1 Single 200 mg dose of vepdegestrant registrational tablet in Period 1 followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2
Sequence 2 Single 200 mg dose of vepdegestrant variant tablet in Period 1 followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2
Participants will be in the study for about 11 weeks
This study is seeking male or female participants of non-childbearing potential age who
are 18 years or older
are healthy as decided by medical tests
have a Body mass index BMI of 16 to 32 kilogram per meter squared and a total body weight of more than 45 kilograms 99 pounds
All participants will be put into groups to receive one of the 2 treatments in each period This study will consist of 2 treatment sequences
Sequence 1 Single 200 mg dose of vepdegestrant registrational tablet in Period 1 followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2
Sequence 2 Single 200 mg dose of vepdegestrant variant tablet in Period 1 followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2
Participants will be in the study for about 11 weeks
Detailed Description:
None
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