Pharmacokinetics and Safety of RV521 Formulations

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: RV521

• Registration Number: NCT04065698
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-13
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-22
• Primary Completion: 2019-09-02
• Study Completion: 2019-09-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RV521	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)

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) for RV521	Baseline to study day 11
Terminal half life (t1/2) 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
Time to maximum plasma concentration (tmax) 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

Name	Time	Method
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)

Trial Locations

Locations (1)

Richmond Pharmacology Ltd; 🇬🇧 London, United Kingdom