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| ID | Type | Description | Link |
|---|---|---|---|
| C5241008 | Other Identifier | Alias Study Number |
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The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir).
This study is looking for healthy adult participants who meet the following criteria:
This study will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg RV521/78 µCi [ 14C]-RV521 | Experimental | 200 mg RV521/78 µCi [ 14C]-RV521 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200 mg RV521/78 µCi [ 14C]-RV521. | Drug | 200 mg RV521/78 µCi [ 14C]-RV521 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax (Time of maximum observed concentration) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| Cmax (Maximum observed concentration) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| AUC0-last (AUC from the time of dosing to the time of the last measurable concentration) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| lambdaz (Rate constant associated with the terminal elimination phase) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| t1/2 (half-life of the terminal elimination phase) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneously reported adverse events (AEs) during the Treatment Period | safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Spontaneously reported serious AEs (SAEs) during the Treatment Period |
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Inclusion Criteria (key):
Exclusion Criteria (key):
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| CL/F (Apparent clearance of the drug from plasma after oral administration) |
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects |
| Day 1 (time 0) to Day 29 |
| Vz/F (Volume of distribution associated with the terminal phase) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| CLR (renal clearance) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| Fe (fraction of administered drug excreted into urine) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval) | PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects | Day 1 (time 0) to Day 29 |
| Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)) | Mass balance parameters in urinary and fecal excretion of radioactivity | Day 1 (time 0) to Day 29 |
| Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g)) | Mass balance parameters in urinary and fecal excretion of radioactivity | Day 1 (time 0) to Day 29 |
| Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %)) | Mass balance parameters in urinary and fecal excretion of radioactivity | Day 1 (time 0) to Day 29 |
| Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0) | Mass balance parameters in urinary and fecal excretion of radioactivity | Day 1 (time 0) to Day 29 |
| 14C associated with % of AUC of the total in plasma | Metabolite Profiling and Identification | Day 1 (time 0) to Day 29 |
| 14C associated with % of administered dose of the total in urine and feces | Metabolite Profiling and Identification | Day 1 (time 0) to Day 29 |
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
| Day -1 to Day 29 |
| Use of concomitant medications | Safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Unscheduled assessments as needed for management of AEs | Safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature) | Safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments | Safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Clinically significant changes from baseline of any of the following: Physical examinations | Safety and tolerability of a single oral dose of RV521 in healthy male subjects | Day -1 to Day 29 |
| Blood/Plasma AUC Ratio | AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma | Day 1 (time 0 to Day 29) |
| Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g) | Metabolite Profiling and Identification | Day 1 (time 0) to Day 29 |
| Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g) | Metabolite Profiling and Identification | Day 1 (time 0 to Day 29) |
| Evaluation of total radioactivity in nasal samples 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 | Day 1 (time 0) to Day 29 |
| Structural identification of major metabolites | Identification of each metabolite that accounts for ≥10% of circulating radiolabel | Day 1 (time 0) to Day 29 |
| D014777 | Virus Diseases |
| D007239 | Infections |