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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01221818
First received: October 14, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Inflammatory Bowel Disease
Drug: E6007
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects [ Time Frame: Day 1 - Day 180 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Obtain a preliminary assessment of the pharmacokinetics of these single doses of E6007 [ Time Frame: Day 1 - Day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2010
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E6007
E6007 25mg single dose or matching placebo
Experimental: 2 Drug: E6007
E6007 50mg single dose or matching placebo
Experimental: 3 Drug: E6007
E6007 100mg single dose or matching placebo
Experimental: 4 Drug: E6007
E6007 200mg single dose or matching placebo
Experimental: 5 Drug: E6007
E6007 400mg single dose or matching placebo
Experimental: 6 Drug: E6007
E6007 600 mg single dose or matching placebo

Detailed Description:

This is a randomized, double-blind, placebo-controlled, ascending single dose study to evaluate the safety and tolerability of E6007 in healthy subjects. Six dose groups will be evaluated. Subjects will receive either 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg E6007 or matching placebo tablets. Subjects will undergo screening evaluations, baseline evaluations, Day 1 (dosing day), and Days 2-5 evaluations. They will also have a follow-up visit on Day 90 and a Day 180 follow-up phone call.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

• 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

Exclusion Criteria:

  • 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
  • Subjects who used prescription drugs within 4 weeks prior to dosing or over-the-counter (OTC) medications within 1 week prior to dosing
  • Subjects who performed strenuous physical activity or exercise within 1 week prior to dosing
  • Subjects who answer affirmatively to any of the following questions on the Study Entry Questionnaire: (1) Do you have any medical condition that may make your body unable to fight infections like leukemia, lymphoma, human immunodeficiency virus (HIV), or organ transplant? (2) Over the last 4 weeks have you been treated for cancer and/or for autoimmune diseases; (3) Have you ever taken natalizumab, rituximab, or efalizumab, alemtuzumab, and mycophenolate, or any immunosuppressive agent known to be associated with Progressive Multifocal Leukoencephalopathy (PML)? (4) Have you taken any of the following medicines over the last 12 months: dexamethasone, bethamethasone, methylprednisolone, budesonide, prednisone, methotrexate, cyclosporine, tacrolimus, enbrel, humira, remicade, azathioprine, 6-MP, chemotherapy-related drugs, anti-tumor necrosis factor (TNF) alpha agents, or any immunosuppressive agent other than those associated with Progressive Multifocal Leukoencephalopathy (PML) such as natalizumab, rituximab, efalizumab, alemtuzumab, or mycophenolate?
  • Positive John Cunningham Polyomavirus (JCV) blood deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) test result at Screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221818

Locations
United States, Washington
Charles River Clinical Services Northwest
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gina Pastino Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01221818     History of Changes
Other Study ID Numbers: E6007-A001-001
Study First Received: October 14, 2010
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014