drugset / Trial / NCT02415790
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of single oral ascending doses of E2027, will be administered to healthy adult participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a broad dose range, to establish the PK/PD relationship.
Timeline
- Start
- 2015-07
- Primary completion
- 2016-06
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irsenontrine | Small molecule | 10 mg | Oral |
| Subject | Irsenontrine | Small molecule | 1200 mg | Oral |
Indications
No indication recorded.