C19007: Pharmacokinetics and Safety of RV521 Formulations

Sponsor

ReViral Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04065698

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

10.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Drug: RV521	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Aug 13, 2019

Actual Primary Completion Date :

Sep 2, 2019

Actual Study Completion Date :

Sep 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RV521 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 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

Arm

Intervention/Treatment

Experimental: RV521

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richmond Pharmacology Ltd	London		United Kingdom	SE1 1YR

Sponsors and Collaborators

ReViral Ltd

Investigators

Principal Investigator: Lorch, MD, Richmond Pharmacology Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ReViral Ltd

ClinicalTrials.gov Identifier:

NCT04065698

Other Study ID Numbers:

REVC005
2019-000976-40

First Posted:

Aug 22, 2019

Last Update Posted:

Jan 2, 2020

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Jan 2, 2020