NCT04065698

Pharmacokinetics and Safety of RV521 Formulations

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-13
• Primary completion: 2019-09-02
• Completion: 2019-09-09
• First posted: 2019-08-22
• Last updated: 2024-06-07

Locations

1 site across 1 country: United Kingdom