Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511, United States
NCT Number: NCT07335419
The purpose of the study is to learn how itraconazole changes how the body processes the study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with itraconazole.
Itraconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with itraconazole.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion
Exclusion
Participants will receive PF-07248144 as a single dose, oral tablet on Day 1 of Period 1 and Day 4 of Period 2 with a washout period between two doses
Participants will receive Itraconazole oral solution once daily on Days 1-12 in Period 2
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
AUClast will be used as the primary endpoint if AUCinf cannot be reliably estimated
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Pfizer
Industry
PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF ITRACONAZOLE ON PF-07248144 PHARMACOKINETICS
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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