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Completed

NCT Number: NCT01673451

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

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).

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Key information

Conditions

CNS Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel, California Clinical Trials, Culver City, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E2006

Drug

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

placebo comparator

Drug

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

Primary outcomes

  1. Incidence of Adverse events (AEs)

    Time frame: 28 days

Secondary outcomes

  1. Plasma concentrations of E2006

    Time frame: Part A up to 288 hours postdose; Part B: up to 324 hours postdose

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2012
Registry last updated
Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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