NCT03373903

Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

A Multicenter, Dose-finding Study to Determine if Oral BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in Elderly Subjects

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: Restorbio Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in elderly subjects.

Detailed description

This is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of BEZ235 alone and in combination with RAD001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. The study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
OTHER	Placebo	oral
DRUG	BEZ235	oral
DRUG	BEZ235 plus everolimus (RAD001)	Oral

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-05-03
• Completion: 2018-07-01
• First posted: 2017-12-14
• Last updated: 2018-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study