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SUVN-G3031 Safety, Tolerability, and Pharmacokinetics

Completed

This Phase I study will investigate the safety, tolerability, and pharmacokinetics of the experimental drug SUVN-G3031 in healthy male subjects.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 45 Years Male Accepts Healthy Volunteers
September 2014
August 2015
64

  • Healthy male aged 18 to 45 years with a Body Mass Index between 18 and 30 kg/m2 (inclusive)

  • History of clinically significant disease or disorder that could influence the study volunteer's safety or ability to participate in the study
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. Participants will take either the study drug, SUVN-G3031, or a placebo. Taken as an oral medication, SUVN-G3031 is a histamine H3 antagonist being tested as a treatment for cognitive dysfunction associated with Alzheimer's disease. The drug blocks the H3 receptor, allowing the naturally occurring compound histamine to be produced.

Name City State Zip Status Primary Contact
Quintiles
Overland Park Kansas 66211

Suven Life Sciences Ltd.

Name Role Affiliation
Murtaugh Thomas, MD Principal Investigator Senior Medical Research Director

Name Phone Email
Katrina Walters 913-708-6745 katrina.walters@quintiles.com

NCT02342041

A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects