Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Low Dose PF-07328948
PF-07328948 · 7 trials · 5 indications
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).
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
if data permits
If AUCinf cannot be completed
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes \<0.8 x lower limit of normal (LLN) or \>1.2 x upper limit of normal (ULN); Neutrophils \<0.8 x LLN; Neutrophils/Leukocytes \<0.8 x LLN; Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; Bilirubin \>1.5 x ULN; Indirect Bilirubin \>1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) \>20.
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline
Maximum increase from baseline in ECG Mean Heart Rate was reported.
Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported.
| Arm | Type | Description |
|---|---|---|
| Period 1/Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension. |
| Period 3/Treatment C | EXPERIMENTAL | Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month |
| Period 4/Treatment D | EXPERIMENTAL | Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets |
| Period 2/Treatment B | EXPERIMENTAL | Participants will receive a single tablet of unlabeled oral dose of PF-07328948; \~ 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948 |
| Arm 1 | EXPERIMENTAL | Participants will receive oral daily PF-07328948 tablet for 7 consecutive days. |
| Group 1: PF-07328948 participants without renal impairment | EXPERIMENTAL | Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 2: PF-07328948 participants with severe renal impairment | EXPERIMENTAL | Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 3: PF-07328948 participants with moderate renal impairment | EXPERIMENTAL | Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 4: PF-07328948 participants without hepatic impairment | EXPERIMENTAL | Participants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 2: PF-07328948 participants with moderate hepatic impairment | EXPERIMENTAL | Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 3: PF-07328948 participants with mild hepatic impairment | EXPERIMENTAL | Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 1: PF-07328948 participants with severe hepatic impairment | EXPERIMENTAL | Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Period 1 | EXPERIMENTAL | PF-07328948 |
| Period 2 | EXPERIMENTAL | cyclosporine and PF-07328948 |
| Period 3 (optional) | EXPERIMENTAL | clarithromycin and PF-07328948 |
| PF-07328948 and Placebo (Cohort 1) | EXPERIMENTAL | Dose level 1: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 2) | EXPERIMENTAL | Dose level 2: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 3) | EXPERIMENTAL | Dose level 3: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 4) | EXPERIMENTAL | Dose level 4: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 5) | EXPERIMENTAL | Dose level 5: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 10) | EXPERIMENTAL | Optional cohort - Multiple dose administration of PF-07328948 and placebo over 14 days in healthy Japanese participants; 5 participants will receive PF-07328948 and 1 will receive placebo |
| PF-07328948 and Placebo (Cohort 7) | EXPERIMENTAL | Dose level 7: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 8) | EXPERIMENTAL | Optional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 oral tablet and oral suspension (Cohort 11) | EXPERIMENTAL | Assessment of relative bioavailability PF-07328948 oral tablet compared to PF-07328948 oral suspension under fed and fasted condition; 12 participants will be enrolled, and 6 participants randomized to 1 of 2 sequences |
| PF-07328948 and Placebo (Cohort 6) | EXPERIMENTAL | Dose level 6: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| PF-07328948 and Placebo (Cohort 9) | EXPERIMENTAL | Optional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo |
| Cohort 1 | EXPERIMENTAL | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
| Cohort 2 | EXPERIMENTAL | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
| Cohort 3 | EXPERIMENTAL | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
| Name | Type | Description |
|---|---|---|
| Oral [14C]PF-07328948 | DRUG | A single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional) |
| Oral Unlabeled PF-07328948 | DRUG | A single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion) |
| IV [14C]PF-07328948 | DRUG | A single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 administered as tablets. |
| PF-07328948 | DRUG | Oral tablet |
| cyclosporine | DRUG | 600 mg capsule day 12 (Part A) |
| clarithromycin | DRUG | 500 mg tablets twice daily day 1 to day 6 (Part B) |
| Placebo | DRUG | Placebo will be administered as oral suspensions BID over 14 days |
Inclusion Criteria * Male participants aged ≥18 years to \<65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 17.5-32 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Crit...
Low Dose PF-07328948 is an investigational small molecule being developed by Pfizer for cardiovascular conditions, specifically heart failure. It is currently in Phase 2 clinical trials for heart failure, with additional Phase 1 studies in healthy adults and in people with hepatic or renal impairment.
Low Dose PF-07328948 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting multiple clinical trials to evaluate the drug in various populations, including healthy adults and patients with heart failure.
Low Dose PF-07328948 is in Phase 2 clinical development for heart failure, as shown by the recruiting BRANCH-HF trial. It is also being studied in Phase 1 trials for hepatic and renal impairment. The drug is investigational and has not been approved by regulatory authorities.
Low Dose PF-07328948 is being studied in several trials. NCT06991257 is a Phase 2 study in adults with heart failure. NCT06837259 is a completed Phase 1 drug interaction study in healthy adults. NCT07269301 and NCT07315360 are Phase 1 studies in hepatic and renal impairment, respectively.
Yes, Low Dose PF-07328948 is the same as PF-07328948. The drug is referred to by both names in clinical trial records, with PF-07328948 being the primary identifier used in study titles and descriptions.
Low Dose PF-07328948 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for heart failure and Phase 1 trials for other conditions. Approval status has not been granted, and the drug remains in clinical development.