Pharmacokinetics and Safety of RV521 Formulations (C19007)

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

The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: RV521

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 1YR
    • Richmond Pharmacology Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RV521; 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; 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.; Other Names: Sisunatovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Principal Investigator: Lorch, MD, Richmond Pharmacology Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: REVC005; 2019-000976-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No