Healthy SubjectsPhase 1NCT02533102
Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers
A Phase 1 study testing E7050 in people with Healthy Subjects, run by Eisai Limited at 1 site in Netherlands.
Trial summary
This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E7050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Feb 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in this study:
- Normal healthy adult males and females (age 18-45 years).
- Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening.
- Pregnancy or lactation. Female patients of childbearing potential must have a negative pregnancy test before inclusion into the study, and must agree to use medically acceptable methods of contraception (eg, abstinence, condom + spermicide, or a double-barrier method [eg, condom + diaphragm with spermicide], or intrauterine device (IUD), or have a vasectomised partner) starting at Screening and throughout the entire study period and for 2 months after the last dose of study drug. Those female patients using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Cycle 1 Day 1, and continuing throughout the entire study period and for 2 months after the last dose of study drug. Postmenopausal women must have been amenorrheic for at least 12 consecutive months; otherwise a pregnancy test is required. Male patients must agree to use contraceptive methods (eg, abstinence, condom + spermicide or a double-barrier method [eg, condom + partner diaphragm with spermicide]).
- Non-smokers.
- Willing and able to comply with all aspects of the protocol.
- Provide written informed consent.
Who cannot join
- Participants who meet any of the following criteria will be excluded from this study:
- 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.
- 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.
- Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline.
- An interval corrected for heart rate (QTcF) interval greater than 450 msec at Screening or Baseline.
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- Females who are either pregnant or lactating.
- A known or suspected history of drug or alcohol abuse within 6 months prior to screening, or who have a positive urine drug test or alcohol test at Screening or Baseline.
- Positive results for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen.
- Diagnosis of acquired immune deficiency syndrome (AIDS), or positive test for human immunodeficiency virus (HIV).
- Participation in another clinical trial less than 4 weeks prior to dosing or current enrollment in another clinical trial.
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week prior to dosing.
- Hemoglobin level less than 12.0 g/dL.
- Known history of any significant drug or food allergy or an ongoing seasonal allergy.
- Use of prescription drugs within 2 weeks prior to Screening (unless drug has a long t1/2, ie, 5 x t1/2 exceeds 2 weeks).
- Use of over-the-counter (OTC) medications within a minimum of 2 weeks prior to dosing.
- Requiring a special diet or taking dietary aids known to modulate drug metabolizing enzymes, or who have consumed foods/beverages or herbal preparations containing Kava root, Ginkgo Biloba Extract (GBE), or St. John's Wort within 4 weeks of Baseline Period 1.
- Known intolerance to the study drug (or any of the excipients).
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of E7050 Pharmacokinetics After 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics After 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects
This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.
- Conditions
- Healthy Subjects
- Being tested
- E7050
- Keywords
- Pharmacokinetics, E7050, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7050Drug
100 mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: E7050 100 mg tablet under fasted conditions | Experimental | Participants will receive a single tablet containing 100 mg E7050 following an overnight fast. Receives: Drug: E7050 |
| Part A: E7050 100 mg tablet with low-fat breakfast | Experimental | Participants will receive a single tablet containing 100 mg E7050 with a standard low-fat meal. Receives: Drug: E7050 |
| Part A: E7050 100 mg tablet with high-fat breakfast | Experimental | Participants will receive a single tablet containing 100 mg E7050 with a standard high-fat meal. Receives: Drug: E7050 |
| Part B: E7050 200 mg tablet under fasted conditions | Experimental | Participants will receive a single dose of 200 mg (two 100 mg tablets) of E7050 under fasted conditions. Receives: Drug: E7050 |
| Part B: E7050 400 mg tablet under fasted conditions | Experimental | Participants will receive a single dose of 400 mg (four 100 mg tablets) of E7050 under fasted conditions. Receives: Drug: E7050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration)
Measured: 0 hour to 168 hours
E7050 pharmacokinetic parameter: Cmax (maximum observed plasma concentration)
Measured: 0 hour to 168 hours
E7050 pharmacokinetic parameter: t lag (time point immediately prior to the first quantifiable concentration)
Measured: 0 hour to 168 hours
E7050 pharmacokinetic parameter: AUC 0-t (area under the plasma concentration-time profile from time 0 to the last measurable concentration)
Measured: 0 hour to 168 hours
E7050 pharmacokinetic parameter: AUC 0-inf (area under the plasma concentration-time profile from time 0 to infinity)
Measured: 0 hour to 168 hours
E7050 pharmacokinetic parameter: t1/2 (the terminal half-life)
Measured: 0 hour to 168 hours
Secondary outcomes (1)
Number of participants as a measure of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533102
- Sponsor's protocol ID
- E7050-E044-004
- Status last verified
- Nov 2015
- First submitted
- 24 Aug 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of E7050 Pharmacokinetics After 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics After 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02533102
- Acronym / sponsor ID
- E7050-E044-004
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, E7050, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Aug 2015 (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 study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: E7050 100 mg tablet under fasted conditions | Experimental | Drug: E7050Participants will receive a single tablet containing 100 mg E7050 following an overnight fast. |
| Part A: E7050 100 mg tablet with low-fat breakfast | Experimental | Drug: E7050Participants will receive a single tablet containing 100 mg E7050 with a standard low-fat meal. |
| Part A: E7050 100 mg tablet with high-fat breakfast | Experimental | Drug: E7050Participants will receive a single tablet containing 100 mg E7050 with a standard high-fat meal. |
| Part B: E7050 200 mg tablet under fasted conditions | Experimental | Drug: E7050Participants will receive a single dose of 200 mg (two 100 mg tablets) of E7050 under fasted conditions. |
| Part B: E7050 400 mg tablet under fasted conditions | Experimental | Drug: E7050Participants will receive a single dose of 400 mg (four 100 mg tablets) of E7050 under fasted conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal healthy adult males and females (age 18-45 years).
- Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening.
- Pregnancy or lactation. Female patients of childbearing potential must have a negative pregnancy test before inclusion into the study, and must agree to use medically acceptable methods of contraception (eg, abstinence, condom + spermicide, or a double-barrier method [eg, condom + diaphragm with spermicide], or intrauterine device (IUD), or have a vasectomised partner) starting at Screening and throughout the entire study period and for 2 months after the last dose of study drug. Those female patients using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Cycle 1 Day 1, and continuing throughout the entire study period and for 2 months after the last dose of study drug. Postmenopausal women must have been amenorrheic for at least 12 consecutive months; otherwise a pregnancy test is required. Male patients must agree to use contraceptive methods (eg, abstinence, condom + spermicide or a double-barrier method [eg, condom + partner diaphragm with spermicide]).
- Non-smokers.
- Willing and able to comply with all aspects of the protocol.
Key exclusion criteria (19 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.
- 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.
- Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline.
- An interval corrected for heart rate (QTcF) interval greater than 450 msec 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 |
|---|---|---|
| E7050100 mg tablet administered orally | Drug | Part A: E7050 100 mg tablet under fasted conditions, Part A: E7050 100 mg tablet with high-fat breakfast, Part A: E7050 100 mg tablet with low-fat breakfast, Part B: E7050 200 mg tablet under fasted conditions, Part B: E7050 400 mg tablet under fasted conditions |
Primary outcome
E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration)
Time frame: 0 hour to 168 hours
E7050 pharmacokinetic parameter: Cmax (maximum observed plasma concentration)
Time frame: 0 hour to 168 hours
E7050 pharmacokinetic parameter: t lag (time point immediately prior to the first quantifiable concentration)
Time frame: 0 hour to 168 hours
E7050 pharmacokinetic parameter: AUC 0-t (area under the plasma concentration-time profile from time 0 to the last measurable concentration)
Time frame: 0 hour to 168 hours
E7050 pharmacokinetic parameter: AUC 0-inf (area under the plasma concentration-time profile from time 0 to infinity)
Time frame: 0 hour to 168 hours
E7050 pharmacokinetic parameter: t1/2 (the terminal half-life)
Time frame: 0 hour to 168 hours
1 secondary outcome
Number of participants as a measure of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 9 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 20 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 E7050 in people with Healthy Subjects, run by Eisai Limited at 1 site in Netherlands.
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 7 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 20 Nov 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 Netherlands. 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?
E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration) (time frame: 0 hour to 168 hours). The study lists 6 primary outcomes in all. 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 20 Nov 2015.