A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

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Eisai

Status and phase

Completed
Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: E2212
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01221259
E2212-A001-001

Details and patient eligibility

About

This study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and Cerebrospinal (CSF) following single oral doses of E2212.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
  • Body mass index (BMI) 18 and 30 kg/m2 at Screening;
  • Are willing and able to comply with all aspects of the protocol; and
  • Provide written informed consent.

Exclusion criteria

  • Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
  • History of serious medical illness
  • Smoking or use of tobacco-containing products within past 3 months
  • History of alcohol or drug abuse within past 2 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Drug E2212
Experimental group
Treatment:
Drug: E2212
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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