Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT06532383
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 participant's 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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
-Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Bulk powder for extemporaneous preparation for oral solutions.
Bulk powder for extemporaneous preparation for oral solutions
Time frame: Baseline (Day 0) up to 35 days after last dose of study medication
Time frame: Baseline up to Day 4
Time frame: Baseline up to Day 4
Time frame: Baseline up to Day 4
Time frame: Baseline up to Day 4
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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