Inflammatory Bowel DiseasePhase 1NCT01221818
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
A Phase 1 study testing E6007 in people with Inflammatory Bowel Disease, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- E6007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Services Northwest
Tacoma, Washington, 98418
About this study
The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- E6007
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6007Drug
E6007 25mg single dose or matching placebo
E6007Drug
E6007 50mg single dose or matching placebo
E6007Drug
E6007 100mg single dose or matching placebo
E6007Drug
E6007 200mg single dose or matching placebo
E6007Drug
E6007 400mg single dose or matching placebo
E6007Drug
E6007 600 mg single dose or matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E6007 |
| 2 | Experimental | Not described Receives: Drug: E6007 |
| 3 | Experimental | Not described Receives: Drug: E6007 |
| 4 | Experimental | Not described Receives: Drug: E6007 |
| 5 | Experimental | Not described Receives: Drug: E6007 |
| 6 | Experimental | Not described Receives: Drug: E6007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects
Measured: Day 1 - Day 180
Secondary outcomes (1)
Obtain a preliminary assessment of the pharmacokinetics of these single doses of E6007
Measured: Day 1 - Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Pastino, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221818
- Sponsor's protocol ID
- E6007-A001-001
- Status last verified
- Jul 2014
- First submitted
- 14 Oct 2010
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01221818
- Acronym / sponsor ID
- E6007-A001-001
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E6007 |
| 2 | Experimental | Drug: E6007 |
| 3 | Experimental | Drug: E6007 |
| 4 | Experimental | Drug: E6007 |
| 5 | Experimental | Drug: E6007 |
| 6 | Experimental | Drug: E6007 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E6007E6007 25mg single dose or matching placebo | Drug | 1 |
| E6007E6007 50mg single dose or matching placebo | Drug | 2 |
| E6007E6007 100mg single dose or matching placebo | Drug | 3 |
| E6007E6007 200mg single dose or matching placebo | Drug | 4 |
| E6007E6007 400mg single dose or matching placebo | Drug | 5 |
| E6007E6007 600 mg single dose or matching placebo | Drug | 6 |
Primary outcome
Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects
Time frame: Day 1 - Day 180
1 secondary outcome
Obtain a preliminary assessment of the pharmacokinetics of these single doses of E6007
Time frame: Day 1 - Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
Related trials for Inflammatory Bowel Disease
RecruitingPhase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis, Inflammatory Bowel Diseases
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Enrolling by invitationPhase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Ulcerative Colitis, Inflammatory Bowel Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Pastino study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E6007 in people with Inflammatory Bowel Disease, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects (time frame: Day 1 - Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.