Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT06661694
Status:
WITHDRAWN
Last Update Posted:
2025-04-24
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn How Different Tablets of the Study Medicine Mevrometostat Are Taken up Into the Blood in Healthy Adults
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE EFFECT OF TABLET FORMULATION ON THE RELATIVE BIOAVAILABILITY OF MEVROMETOSTAT (PF-06821497)
Status:
WITHDRAWN
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
False
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 of mevrometostat available from four different tablet formulations, taken with food, in healthy adult participants.
This study is seeking male or female participants 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
* a total body weight of more than 50 kilograms (110 pounds).
All participants will take part in 4 study periods to receive 4 different treatments, which are assigned in a random order. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of the next period.
Each treatment consists of a single dose of mevrometostat (PF-06821497), and the treatments differ only by tablet formulation.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after giving each of these tablets. The results will be used to see the effect of tablet formulation on the amount of mevrometostat (PF-06821497) available in the blood of the participants.
Participants will be in the study for about 12 weeks.
This study is seeking male or female participants 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
* a total body weight of more than 50 kilograms (110 pounds).
All participants will take part in 4 study periods to receive 4 different treatments, which are assigned in a random order. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of the next period.
Each treatment consists of a single dose of mevrometostat (PF-06821497), and the treatments differ only by tablet formulation.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after giving each of these tablets. The results will be used to see the effect of tablet formulation on the amount of mevrometostat (PF-06821497) available in the blood of the participants.
Participants will be in the study for about 12 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-516907-18-00 | REGISTRY | CTIS (EU) | View |