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2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01673451
Enrollment
24
Registered
2012-08-28
Start date
2012-08-31
Completion date
2013-07-31
Last updated
2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS

Keywords

insomnia

Brief summary

This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).

Interventions

DRUGE2006

Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules

DRUGPlacebo comparator

E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules

Sponsors

Eisai Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Included: * Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B) * Who report typical time in bed 7.5 to 9 hours * Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00 * Who report typical sleep latency of \<= 30 minutes * All females must be of non-childbearing potential, or subjects who have been sterilized surgically or who are otherwise proven sterile. Females must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening and a negative urine pregnancy test at Baseline. * Body mass index BMI \> 18 and 32 kg/m2 at Screening Excluded: * Performed shift work within 2 weeks prior to Screening * Had taken a flight across three or more time zones in the 7 days prior to Screening * Female subjects who are nursing * With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006 * With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy * Hypersensitivity to the study drug or any of the excipients

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse events (AEs)28 days

Secondary

MeasureTime frame
Plasma concentrations of E2006Part A up to 288 hours postdose; Part B: up to 324 hours postdose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026