Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RV521, PF-07923568, RV521 oral tablet
Sisunatovir · 7 trials · 6 indications
Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data.
Cmax was defined as maximum observed plasma concentration.
Cmax was defined as maximum observed plasma concentration.
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
AUCinf was defined as area under the concentration-time curve from time 0 to infinity.
Cmax was the highest concentration observed directly from data
AUClast was determined using linear/Log trapezoidal method
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment.
Laboratory tests included haematology (Monocytes \[10\^9/L\] increase: \> 1.2\* upper limit of normal \[ULN\] and Monocytes/Leukocytes \[percentage\] {%}:\> 1.2\* ULN); clinical chemistry (serum) included Alanine Aminotransferase (units per liter \[U/L\]):\> 3.0\* ULN and Bicarbonate (milliequivalents per liter) (mEq/L): \>1.1\* ULN and in urinalysis (urine Hemoglobin (Scalar) more than equal to (\>=) 1, urine Bilirubin (Scalar) \>= 1, Hyaline Casts (/Low power field \[LPF\]) \>= 1. Number of participants with any clinical laboratory abnormalities is reported in this outcome.
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Pulse rate was measured in the brachial/radial artery. Notable abnormal vital sign categories included: Systolic BP: \<90 millimeter of mercury \[mmHg\]; Systolic BP change from baseline: maximum increase and decrease \>=30 mmHg; Diastolic BP \<50 mmHg; Diastolic BP change from baseline: maximum decrease and increase ≥20 mmHg; pulse rate \<40 and \>120 beats per minute. Number of participants with newly occurring notable abnormal vital sign (i.e. change in supine systolic BP \>=30 millimeter of mercury \[mmHg\] increase) is reported in this outcome measure.
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG was performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was determined by the investigator.
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
Mass balance parameters in urinary and fecal excretion of radioactivity
Mass balance parameters in urinary and fecal excretion of radioactivity
Mass balance parameters in urinary and fecal excretion of radioactivity
Mass balance parameters in urinary and fecal excretion of radioactivity
Metabolite Profiling and Identification
Metabolite Profiling and Identification
| Arm | Type | Description |
|---|---|---|
| RV521 | EXPERIMENTAL | RV521 drug substance in capsule for oral administration |
| Placebo | PLACEBO_COMPARATOR | Micro-crystalline cellulose in capsule for oral administration |
| Arm 1 | EXPERIMENTAL | This only arm will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state |
| Cohort 1: Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment will receive a single oral dose of PF-07923568 |
| Cohort 2: Normal Renal Function | EXPERIMENTAL | Participants with normal renal function will receive a single oral dose of PF-07923568 |
| Cohort 3 (Optional): Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment will receive a single oral dose of PF-07923568 |
| Healthy subjects | EXPERIMENTAL | One time dose of 4 capsules taken orally. |
| Mild Hepatic impaired subjects | EXPERIMENTAL | One time dose of 4 capsules taken orally. |
| Moderate hepatic impaired subjects | EXPERIMENTAL | One time dose of 4 capsules taken orally |
| Severe Hepatic Impaired Subjects | EXPERIMENTAL | One time dose of 4 capsules taken orally. |
| Group A: Higher dose sisunatovir | EXPERIMENTAL | higher dose of sisunatovir dosed every 12 hours |
| Group B: Lower dose sisunatovir | EXPERIMENTAL | Lower dose of sisunatovir dosed every 12 hours |
| Group C: Placebo | PLACEBO_COMPARATOR | Placebo for sisunatovir dosed every 12 hours |
| Group D: Higher dose of sisunatovir | EXPERIMENTAL | Higher dose of sisunatovir dosed every 12 hours under fasted conditions |
| Group E: sisunatovir palatability | EXPERIMENTAL | Sisunatovir in 4 vehicles (water, saline, apple juice, infant formula) to assess the palatability of sisunatovir in each vehicle. sisunatovir will not be swallowed, participants will swirl and spit to assess various aspects of the taste. |
| 200 mg RV521/78 µCi [ 14C]-RV521 | EXPERIMENTAL | 200 mg RV521/78 µCi \[ 14C\]-RV521 |
| Name | Type | Description |
|---|---|---|
| RV521 | DRUG | RV521 drug in capsules |
| Placebo | DRUG | Placebo in capsules |
| Sisunatovir | DRUG | Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state |
| Drug: PF-07923568 | DRUG | A single dose of PF-07923568 administered orally as 4 capsules |
| PF-07923568 | DRUG | One time dose of 4 capsules taken orally. |
| 200 mg RV521/78 µCi [ 14C]-RV521. | DRUG | 200 mg RV521/78 µCi \[ 14C\]-RV521 |
Inclusion Criteria: * Age 18 to 45 years, inclusive * In good health with no history of major medical conditions * A total body weight ≥ 50 kg and a body mass index (BMI) of \>/=18kg/m2 and \</=30kg/m2 Exclusion Criteria: * Evidence of any clinically significant or currently active major medical ...
Sisunatovir is an investigational small molecule being developed for the treatment of respiratory syncytial virus infection. It is not yet approved for any indication and remains in clinical development. The completed Phase 1 studies enrolled healthy adult volunteers rather than patients with active RSV disease.
Sisunatovir is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer holds the development program for this small molecule antiviral candidate targeting respiratory syncytial virus infection.
Sisunatovir is in Phase 1 clinical development. Two Phase 1 studies have been completed, one in China and one in Belgium, and both enrolled healthy adult volunteers. No later-phase trials in patients with respiratory syncytial virus infection have been reported for this candidate.
Sisunatovir has been studied in two completed Phase 1 trials. NCT05987072 evaluated how the study medicine is tolerated and acts in the bodies of Chinese healthy adults. NCT05712460 assessed the safety, effects, and palatability of sisunatovir in healthy adult participants in Belgium. Both trials enrolled 12 participants each.
Sisunatovir is not approved. It is an investigational small molecule still in Phase 1 clinical development for respiratory syncytial virus infection. The completed studies were early-stage trials in healthy volunteers, which is consistent with a candidate that has not yet advanced to regulatory review.