Pharmacokinetics and Safety of RV521 Formulations

Study Overview
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Brief Summary
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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

Official Title
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An Open-label, Single Dose, Three Sequence Study in Healthy Adult Volunteers to Evaluate the Pharmacokinetics, Safety and Tolerability of RV521 Administered as the Drug in Capsule Formulation in the Fed State and the Dry Powder Blend Formulation Dispersed in Water in the Fed and Fasted States

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: RV521


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RV521<br>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) | Drug: RV521<br>* 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.<br>* Other names: Sisunatovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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) |