Purpose Interaction Safety Studies in Rats and Dogs, Period of Performance: 03/25/2020-03/24/2021. NIDA Ref. No. N01DA-18-8939. FY20

NIH RePORTER · NIH · N01 · $1,113,093 · view on reporter.nih.gov ↗

Abstract

Under this task order, SRI proposes to perform one interaction safety study in rats and one cardiovascular safety interaction study in dogs in response to the TORFP. The objectives of these studies are to determine the safety of a test article in combination with an abused substance (interaction article). The estimated period of performance is January 15, 2020 through January 14, 2021; however, the actual start date is contingent upon receipt of test articles from the client. SRI will perform the Activity A, GLP rat interaction study. The Activity B, GLP dog telemetry study, will be outsourced to Charles River Laboratories (CRL) as the hardware and software currently with SRI needs to be updated by the vendors and validated by SRI’s QAU before any work can be performed. CRL at Ashland, OH site has the validated equipment and software to perform the NIDA required activities. Due to these reasons and in the interest of cost and time for the NIDA, SRI has decided to outsource this GLP dog telemetry study to the lab that performs this type of study frequently and has previously conducted a NIDA study with similar study design. SRI will serve as the study monitor for the study.

Key facts

NIH application ID
10286851
Project number
271201800019I-0-759502000001-1
Recipient
SRI INTERNATIONAL
Principal Investigator
Laura Evans
Activity code
N01
Funding institute
NIH
Fiscal year
2020
Award amount
$1,113,093
Award type
Project period
2020-03-25 → 2021-03-24