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

NCT01673451 | Completed Phase 1

• 1 other identifier: E2006-A001-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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).

Conditions

CNS

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse events (AEs)

  28 days

Secondary Outcomes (1)

• Plasma concentrations of E2006

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

Study Arms (2)

Placebo comparator

PLACEBO COMPARATOR

Drug: Placebo comparator

E2006

EXPERIMENTAL

Drug: E2006

Interventions

E2006 DRUG

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

E2006

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

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Parexel, California Clinical Trials

Culver City, California, 90232, United States

Location

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dohwa Kim

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

US (2)