Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532383
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 1 RANDOMIZED DOUBLE-BLIND SPONSOR-OPEN PLACEBOCONTROLLED SINGLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY TOLERABILITY AND PHARMACOKINETICS OF PF-07940369 IN HEALTHY ADULT PARTICIPANTS
Status:
RECRUITING
Status Verified Date:
2024-09
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 evaluate the safety tolerability and Pharmacokinetics Pharmacokinetics PK to better understand how the drug is changed and eliminated from your body after you take it of single ascending oral doses of PF-07940369 in healthy adult participants
This study is seeking participants who
are male or female that are not of childbearing potential of 18 years of age or older
are examined to be healthy
All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses All treatments will be taken by mouth
All participants will remain in the study clinic for 4 days for each treatment for safety review laboratory collections and to collect samples for PK
All participants selected in the study will be required to go through a screening period up to 28 days A screening period is the time during which a few participants are examined to see whether they are fit for the study During this period the participants medical history and past and current medications will be reviewed A series of tests will also be performed to see if they are good to be selected for the study If the participant meets all required criteria and are interested in continuing the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period On day 4 the participant will be discharged About 28 to 35 days after discharge following the final treatment the participant will be contacted for a follow up visit either in person or by telephone This is to check up on how the participant is doing and to conclude the study
This study is seeking participants who
are male or female that are not of childbearing potential of 18 years of age or older
are examined to be healthy
All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses All treatments will be taken by mouth
All participants will remain in the study clinic for 4 days for each treatment for safety review laboratory collections and to collect samples for PK
All participants selected in the study will be required to go through a screening period up to 28 days A screening period is the time during which a few participants are examined to see whether they are fit for the study During this period the participants medical history and past and current medications will be reviewed A series of tests will also be performed to see if they are good to be selected for the study If the participant meets all required criteria and are interested in continuing the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period On day 4 the participant will be discharged About 28 to 35 days after discharge following the final treatment the participant will be contacted for a follow up visit either in person or by telephone This is to check up on how the participant is doing and to conclude the study
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