NCT01294540
Completed
Phase 1
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Alzheimer's Disease
- Sponsor
- Eisai Inc.
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Safety and tolerability as evidenced by the number of subjects with adverse events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.
Detailed Description
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo Comparator: 2
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability as evidenced by the number of subjects with adverse events
Time Frame: 38 days
Secondary Outcomes
- To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses(4 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male ParticipantsJapanese Healthy Adult Male ParticipantsNCT03237156Takeda24
Recruiting
Phase 1
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy SubjectsDyslipidemiaNCT0666942972
Completed
Phase 1
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction StudyHealthy VolunteersNCT01549106SecuraBio106
Completed
Phase 1
BN201 SAD MAD Study in Healthy SubjectsOptic NeuritisOptic; Neuritis, With DemyelinationNCT03630497Accure Therapeutics48
Completed
Phase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male ParticipantsHealthy VolunteersNCT01964872Janssen Cilag N.V./S.A.84