Pharmacokinetics and Safety of RV521 Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2019-09-09

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

RV521

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sisunatovir

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes