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NCT02415790 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT02415790 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 112 participants.
The verdict
NCT02415790, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study 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.
Interventions
- DRUG E2027
- DRUG E2027 matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02415790
The ClinicalTrials.gov registry entry for NCT02415790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which E2027 is the first listed.
NCT02415790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02415790 about?
NCT02415790 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects". 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...
What is the current status of trial NCT02415790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2015-07. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02415790?
The interventions under investigation include: E2027 (DRUG), E2027 matching placebo (DRUG).
Who is sponsoring clinical trial NCT02415790?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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