A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects

NCT01221818 | Completed Phase 1

• 1 other identifier: E6007-A001-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects

  Day 1 - Day 180

Secondary Outcomes (1)

• Obtain a preliminary assessment of the pharmacokinetics of these single doses of E6007

  Day 1 - Day 5

Study Arms (6)

1

EXPERIMENTAL

Drug: E6007

2

EXPERIMENTAL

Drug: E6007

3

EXPERIMENTAL

Drug: E6007

4

EXPERIMENTAL

Drug: E6007

5

EXPERIMENTAL

Drug: E6007

6

EXPERIMENTAL

Drug: E6007

Interventions

E6007 DRUG

E6007 25mg single dose or matching placebo

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking , male or female subjects aged 18-55 years old and with a body mass index (BMI) between 18 and 30 kg/m2 at the time of screening

You may not qualify if:

• Evidence of clinically significant infection, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, rheumatologic, or musculoskeletal system abnormality based on medical history, physical examination, and screening lab assessments
• History of any gastrointestinal surgery that could impact the absorption of drug
• Evidence of clinically significant cardiovascular abnormality
• Family history of sudden death attributed to cardiac arrhythmia or QTc problems, additional risk factors for torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of long QT syndrome)
• Known or suspected history of drug or alcohol misuse within 6 months prior to screening, or positive drug or alcohol test
• Positive hepatitis B or C at screening
• Screening laboratory values outside the normal range or have been diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV)
• Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory assessments at screening
• Known history of any significant drug or food allergy or an ongoing seasonal allergy
• Known neurological or psychiatric disorder that could impact a neurological assessment
• Known history of autoimmune disease
• History of cancer
• Participated in another clinical trial less than 4 weeks prior to dosing
• Subjects who have received blood products within 4 weeks, donated blood within 8 weeks or donated plasma within 1 week of dosing
• Subjects who have taken dietary supplements (including vitamins), juice, and herbal preparations or other foods or beverage that may affect the various drug metabolizing enzymes and transporters (eg, alcohol, grapefruit, grapefruit juice and charbroiled meats) within 1 week prior to dosing

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Charles River Clinical Services Northwest

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gina Pastino

  Eisai Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

US (1)