A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-07328948: PF-07328948, 1 tablet orally, once on Day 1
Study summary
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
Study is seeking participants who:
* Are between 18 and 75 years of age.
* Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.
Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days.
During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.
Eligibility
Primary outcome measure(s)
- Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration). - Unbound AUCinf (AUCinf,u) of PF-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf. - Unbound Cmax (Cmax,u) of PF-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Orange County Research Center | Lake Forest | California | Recruiting |
| Orlando Clinical Research Center | Orlando | Florida | Recruiting |
| Genesis Clinical Research, LLC | Tampa | Florida | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07269301 on ClinicalTrials.gov ↗ ← All trials in the USA