SUVN-G3031 Safety, Tolerability, and Pharmacokinetics
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|
- 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.
Suven Life Sciences Ltd.
|Murtaugh Thomas, MD||Principal Investigator||Senior Medical Research Director|
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