Clinical trial NCT04065698: Pharmacokinetics and Safety of RV521 Formulations
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to maximum plasma concentration (tmax) for RV521
timeFrame: Baseline to study day 11
measure: Terminal half life (t1/2) for RV521
timeFrame: Baseline to study day 11
measure: Maximum observed plasma concentration (Cmax) for RV521
timeFrame: Baseline to study day 11
measure: Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521
timeFrame: Baseline to study day 11
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521
timeFrame: Baseline to study day 11
Secondary outcomes:
measure: Incidence of treatment emergent adverse events as assessed by CTCAE V5.0
timeFrame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
measure: Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
timeFrame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
measure: Proportion of subjects with morphological and/or rhythm abnormalities on ECG
timeFrame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
measure: Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)
timeFrame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
measure: Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)
timeFrame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd
Study officials:
affiliation: Richmond Pharmacology Limited
name: Lorch, MD
role: PRINCIPAL_INVESTIGATOR
References: