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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000976-40 | EudraCT Number |
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The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV521 | Experimental | Three single 200 mg oral doses of RV521 administered on Day 1, Day 5 and Day 9 as either the drug in capsule (1 dosing occasion) or the dry powder blend dispersed in water (2 dosing occasions) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV521 | Drug | Single doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (tmax) for RV521 | Baseline to study day 11 | |
| Terminal half life (t1/2) for RV521 | Baseline to study day 11 | |
| Maximum observed plasma concentration (Cmax) for RV521 | Baseline to study day 11 | |
| Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521 | Baseline to study day 11 | |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521 | Baseline to study day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events as assessed by CTCAE V5.0 | Screening to final study visit (performed at 7 days following the last dose of any intervention) | |
| Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorch, MD | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd | London | SE1 1YR | United Kingdom |
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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| ID | Term |
|---|---|
| C000717948 | sisunatovir |
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| Screening to final study visit (performed at 7 days following the last dose of any intervention) |
| Proportion of subjects with morphological and/or rhythm abnormalities on ECG | Screening to final study visit (performed at 7 days following the last dose of any intervention) |
| Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals) | Screening to final study visit (performed at 7 days following the last dose of any intervention) |
| Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate) | Screening to final study visit (performed at 7 days following the last dose of any intervention) |
| D014777 | Virus Diseases |
| D007239 | Infections |