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VX-787 in healthy volunteers inoculated with influenza
NCT01561807Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2012
- Primary completion
- Oct 2012
- Countries
- 1
- Sponsor
- Vertex Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- pimodivir
- Conditions
- influenza
01
Overview
Phase 2, randomised, double-blind trial of pimodivir in influenza (4 arms), sponsored by Vertex Pharmaceuticals. Primary endpoint: Viral Area Under the Curve (cell culture) at 11 days. Started Mar 2012; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
787 low dose
VX-787 low dose capsule, taken orally for 5 days
787 high dose
VX-787 high dose capsule, taken orally for 5 days
Placebo low dose
Matching placebo low dose capsule, taken orally for 5 days
Placebo high dose
Matching placebo high dose capsule, taken orally for 5 days
03
Who it enrols
Healthy adult volunteers with no significant medical history, specifically excluding those with asthma, COPD, or heart failure, and those who smoke regularly.
04
Endpoints
Primary
Viral Area Under the Curve (cell culture)
Secondary
Safety and Tolerability
Total Mucus Weight
Composite Symptom Score Area Under the Curve
Pharmacokinetic Parameters of VX-787
Viral Area Under the Curve (RT-PCR)
Duration of Viral Shedding
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