Pharmacokinetics and Safety of RV521 Formulations (C19007)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: RV521

Study type: Interventional

Funder types: Industry

Identifiers

NCT04065698

REVC005

2019-000976-40 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

RV521

Experimental group

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)

Treatment:

Drug: RV521