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Completed

NCT Number: NCT04065698

Pharmacokinetics and Safety of RV521 Formulations

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

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology Ltd

London, SE1 1YR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Sisunatovir

Primary outcomes

  1. Time to maximum plasma concentration (tmax) for RV521

    Time frame: Baseline to study day 11

  2. Terminal half life (t1/2) for RV521

    Time frame: Baseline to study day 11

  3. Maximum observed plasma concentration (Cmax) for RV521

    Time frame: Baseline to study day 11

  4. Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521

    Time frame: Baseline to study day 11

  5. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521

    Time frame: Baseline to study day 11

Secondary outcomes

  1. Incidence of treatment emergent adverse events as assessed by CTCAE V5.0

    Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)

  2. Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)

    Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)

  3. Proportion of subjects with morphological and/or rhythm abnormalities on ECG

    Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)

  4. Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)

    Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)

  5. Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)

    Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: C19007

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2019
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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