Pharmacokinetics and Safety of RV521 Formulations

Respiratory Syncytial Virus Infections Clinical Trial

— C19007  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065698
• Other study ID #: REVC005
• Secondary ID: 2019-000976-40
• Status: Completed
• Phase: Phase 1
• Start date: August 13, 2019
• Est. completion date: September 9, 2019

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 9, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to maximum plasma concentration (tmax) for RV521		Baseline to study day 11
Primary	Terminal half life (t1/2) for RV521		Baseline to study day 11
Primary	Maximum observed plasma concentration (Cmax) for RV521		Baseline to study day 11
Primary	Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521		Baseline to study day 11
Primary	Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521		Baseline to study day 11
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)