NCT01673880

Brief Summary

This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

August 22, 2012

Last Update Submit

May 20, 2013

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of E2006 of tablet vs. capsule formulations

    up to 336 hours post-dose

Secondary Outcomes (1)

  • Incidence of adverse events (AEs)

    36 days

Study Arms (3)

E2006 2.5 mg

OTHER
Drug: E2006

E2006 10mg

OTHER
Drug: E2006

E2006 25 mg

OTHER
Drug: E2006

Interventions

E2006DRUG

2.5 mg, 10 mg, and 25 mg E2006 tablets

E2006 10mgE2006 2.5 mgE2006 25 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females,
  • ages 18 to 55 years
  • Body mass index (BMI) \>
  • and 32 kg/m2 at Screening

You may not qualify if:

  • Female subjects who are nursing
  • Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006
  • Subjects with a known history of clinically significant drug or food allergies
  • Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Development, LLC

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Aziz Laurent

    PPD Development, LP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 28, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

May 22, 2013

Record last verified: 2013-03

Locations

US(1)