Pharmacokinetics and Safety of RV521 Formulations

NCT04065698 | Completed Phase 1

• 2 other identifiers: REVC0052019-000976-40
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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)

Study Arms (1)

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)

Drug: RV521

Interventions

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.

Also known as: Sisunatovir

RV521

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Richmond Pharmacology Ltd

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

sisunatovir

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Lorch, MD

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: August 13, 2019
• Primary Completion: September 2, 2019
• Study Completion: September 9, 2019
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)