A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-74
SponsorPfizer
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, at the screening visit.
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lb).
Group 4 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
Disqualifiers
Any condition possibly affecting drug absorption
At screening, a positive result for HIV antibodies.
Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Trial design
Design model
Parallel
Treatments tested in this trial
PF-07328948
DrugPF-07328948, 1 tablet orally, once on Day 1
Treatment groups
26 Participants
are divided into 4 treatment groupsGroup A: Group 4: PF-07328948 participants without hepatic impairmentExperimental treatment 1 intervention
Group B: Group 2: PF-07328948 participants with moderate hepatic impairmentExperimental treatment 1 intervention
Group C: Group 3: PF-07328948 participants with mild hepatic impairmentExperimental treatment 1 intervention
Group D: Group 1: PF-07328948 participants with severe hepatic impairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
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).
Time frame
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 12
Unbound AUCinf (AUCinf,u) of PF-07328948
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.
Time frame
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 13
Unbound Cmax (Cmax,u) of PF-07328948
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
Time frame
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 1Secondary outcomes
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame
Day 1 to Day 36 Source ClinicalTrials.gov