CancerPhase 1NCT01240408
E7080 Food Effect Study in Healthy Subjects
A Phase 1 study testing HOPE in people with Cancer, run by Eisai Inc. at 1 site in United States.
Trial summary
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- HOPE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 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, male or female subjects age greater than or equal to 18 years and less than or equal to 55 years old;
- Body mass index (BMI) greater than 18 and less than or equal to 32 kg/m2 at Screening;
- All females must have a negative serum B-human chorionic gonadotropin (B-hCG) test result or negative urine pregnancy test results at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception (eg, abstinence, an intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomised partner) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as greater than age 50 and with at least 12 months of amenorrhea) or subjects who have been sterilized surgically or who are otherwise proven sterile (eg, bilateral tubal ligation with surgery at least 6 months prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 2 months prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation;
- Male subjects who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug). Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously);
- Provide written informed consent;
- Are willing and able to comply with all aspects of the protocol.
Who cannot join
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug;
- A clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks, of dosing;
- Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history;
- History of clinically significant drug or food allergies or presently experiencing seasonal allergies;
- Evidence of clinically significant deviation from normal in physical examination, vital signs, electrocardiograms (ECG) or clinical laboratory determinations at Screening or Baseline;
- Clinically significant ECG abnormality including a marked baseline prolongation of QT/QTc interval (eg repeated demonstration of a QTc interval greater than 500 msec), or a family history of prolonged QTc syndrome or sudden death;
Show all 21Show fewer
- History of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test at Screening or Baseline;
- Positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen, or a positive syphilis screen;
- Diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV);
- Participated in another clinical trial less than 4 weeks prior to dosing or who are currently enrolled in another clinical trial;
- Consumed caffeinated beverages or food within 72 hours prior to dosing;
- Consumed grapefruit or grapefruit containing beverages or food within 72 hours prior to dosing;
- Experienced a weight loss or gain of greater than 10% within 4 weeks of dosing;
- Engaged in heavy exercise (greater than or equal to 1 hour/day 5 times/week) less than 2 weeks prior to Baseline (eg, marathon runners, weight lifters, etc.);
- Received blood products within 4 weeks, or donated blood within 8 weeks, or donated plasma within 1 week, of dosing;
- Hemoglobin level less than 12.0 g/dL;
- Used prescription drugs within 2 weeks prior to screening;
- Taken over-the-counter (OTC) medications within 2 weeks prior to dosing;
- Any condition that would make him/her in the opinion of the Investigator or Sponsor, unsuitable for the study or who, in the opinion of the Investigator, is not likely to complete the study for any reason;
- Inability to tolerate venepuncture and/or venous access;
- History of depression, deliberate self harm or suicidal ideation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Studies, NW
Tacoma, Washington, 98418
About this study
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.
- Conditions
- Cancer
- Being tested
- HOPE
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPEDrug
Also called E7080
10 mg lenvatinib (1x10 mg lenvatinib capsule) with food
HOPEDrug
Also called E7080
10 mg lenvatinib (1x10 mg lenvatinib capsule) without food
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | 10 mg lenvatinib (1x10 mg lenvatinib capsule) with food Receives: Drug: HOPE |
| Treatment group 2 | Experimental | 10 mg lenvatinib (1x10 mg lenvatinib capsule) without food Receives: Drug: HOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of food on the bioavailability of lenvatinib.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240408
- Sponsor's protocol ID
- E7080-A001-003
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2010
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E7080 Food Effect Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01240408
- Acronym / sponsor ID
- E7080-A001-003
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- First posted
- 15 Nov 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.
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: HOPE10 mg lenvatinib (1x10 mg lenvatinib capsule) with food |
| Treatment group 2 | Experimental | Drug: HOPE10 mg lenvatinib (1x10 mg lenvatinib capsule) without food |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, male or female subjects age greater than or equal to 18 years and less than or equal to 55 years old;
- Body mass index (BMI) greater than 18 and less than or equal to 32 kg/m2 at Screening;
- All females must have a negative serum B-human chorionic gonadotropin (B-hCG) test result or negative urine pregnancy test results at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception (eg, abstinence, an intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomised partner) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as greater than age 50 and with at least 12 months of amenorrhea) or subjects who have been sterilized surgically or who are otherwise proven sterile (eg, bilateral tubal ligation with surgery at least 6 months prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 2 months prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation;
- Male subjects who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug). Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously);
- Provide written informed consent;
Key exclusion criteria (21 listed)
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug;
- A clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks, of dosing;
- Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history;
- History of clinically significant drug or food allergies or presently experiencing seasonal allergies;
- Evidence of clinically significant deviation from normal in physical examination, vital signs, electrocardiograms (ECG) or clinical laboratory determinations at Screening or Baseline;
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 |
|---|---|---|
| HOPEAlso: E708010 mg lenvatinib (1x10 mg lenvatinib capsule) with food | Drug | Treatment group 1 |
| HOPEAlso: E708010 mg lenvatinib (1x10 mg lenvatinib capsule) without food | Drug | Treatment group 2 |
Primary outcome
To determine the effect of food on the bioavailability of lenvatinib.
Time frame: 6 weeks
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 4 Mar 2015.
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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.
Study Director 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 HOPE in people with Cancer, 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 6 inclusion and 21 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 4 Mar 2015. 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?
To determine the effect of food on the bioavailability of lenvatinib. (time frame: 6 weeks). 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 4 Mar 2015.