Respiratory Syncytial Virus Infections
Conditions
Brief summary
The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
Interventions
DRUGRV521
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.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing to comply with protocol defined contraception requirements * In good health with no history of major medical conditions * A body mass index (BMI) of 18-25 kg/m\^2, inclusive
Exclusion criteria
* Evidence of any clinically significant or currently active major medical condition * Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening * Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521 | Baseline to study day 11 |
| 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 |
Secondary
| Measure | 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) | 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) |
Countries
United Kingdom
Outcome results
None listed