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Pharmacokinetics and Safety of RV521 Formulations (C19007)

Primary Purpose

Respiratory Syncytial Virus Infections

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

RV521

About this trial

This is an interventional other trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Richmond Pharmacology Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RV521

Arm Description

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)

Outcomes

Primary Outcome Measures

Time to maximum plasma concentration (tmax) for RV521

Terminal half life (t1/2) for RV521

Maximum observed plasma concentration (Cmax) for RV521

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

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

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT04065698

First Posted

August 20, 2019

Last Updated

December 30, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04065698

Brief Title

Pharmacokinetics and Safety of RV521 Formulations

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

August 13, 2019 (Actual)

Primary Completion Date

September 2, 2019 (Actual)

Study Completion Date

September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RV521

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

RV521

Other Intervention Name(s)

Sisunatovir

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to maximum plasma concentration (tmax) for RV521

Time Frame

Baseline to study day 11

Title

Terminal half life (t1/2) for RV521

Time Frame

Baseline to study day 11

Title

Maximum observed plasma concentration (Cmax) for RV521

Time Frame

Baseline to study day 11

Title

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

Title

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

Time Frame

Baseline to study day 11

Secondary Outcome Measure Information:

Title

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

Time Frame