Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly

NCT ID: NCT04139915

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2019-11-15

Brief Summary

The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.

Detailed Description

RTB-101-205 is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, Phase 3 study to determine if RTB101, a selective TORC1 inhibitor, prevents illness associated with respiratory tract infections (defined as clinically symptomatic respiratory illness) in adults ≥65 years of age. This trial is being conducted in follow up to two Phase 2 trials in older adults in which RTB101 10 mg administered once daily for up to 16 weeks during winter cold and flu season was observed to reduce the incidence of respiratory illness associated with respiratory tract infections.

Conditions

Clinically Symptomatic Respiratory Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg daily RTB101

Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks

Group Type: EXPERIMENTAL

Dactolisib

Intervention Type: DRUG

TORC1 inhibitor

Placebo

Oral matching placebo once daily for 16 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule

Interventions

Dactolisib

TORC1 inhibitor

Intervention Type: DRUG

Placebo

Placebo capsule

Intervention Type: DRUG

Other Intervention Names

RTB101; BEZ235

Eligibility Criteria

Inclusion Criteria

• Subjects must be ≥65 years of age
• Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible
• Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period

Exclusion Criteria

• Subjects who are current smokers, stopped smoking ≤ 1 year prior to screening, or have and a ≥ 10 pack year smoking history
• Subjects with a medical history of clinically significant lung diseases (including COPD) other than asthma
• Subjects with current evidence of a serious and/or unstable medical disorder
• Subjects with unstable cardiac conditions
• Subjects with a history of systemic autoimmune diseases
• Subjects with Type I diabetes mellitus
• Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result
• Infection with Hepatitis B (HBV) or Hepatitis C (HCV)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restorbio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Restorbio Inc.

References

Mannick JB, Morris M, Hockey HP, Roma G, Beibel M, Kulmatycki K, Watkins M, Shavlakadze T, Zhou W, Quinn D, Glass DJ, Klickstein LB. TORC1 inhibition enhances immune function and reduces infections in the elderly. Sci Transl Med. 2018 Jul 11;10(449):eaaq1564. doi: 10.1126/scitranslmed.aaq1564.

Reference Type: BACKGROUND

PMID: 29997249 (View on PubMed)

Other Identifiers

RTB-101-205

Identifier Type: -

Identifier Source: org_study_id