Healthy VolunteersPhase 1NCT01759394
A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
A Phase 1 study testing Avatrombopag maleate 40 mg in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Avatrombopag maleate 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2013
- 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
- Subjects must meet all of the following criteria to be included in this study:
- Healthy male and female subjects (aged 18 to 55 years inclusive, at the time of informed consent)
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2 at Screening
- Platelet count between 120 x 109/L and 300 x 109/L inclusive at Screening, Baseline Period 1, or Baseline Period 3
- Platelet count below the upper limit of normal at Baseline Period 2
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity 25 IU/L or equivalent units of β-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
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- All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, a nonhormonal-based intrauterine device, a double barrier method [such as condom plus spermicide or diaphragm plus spermicide], non-estrogen-based hormonal therapy, progesterone-only contraceptive implant/injection, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. The use of estrogen-based hormonal contraceptives is not allowed because of a potential increase in the risk of venous thrombosis.
- All females who are of reproductive potential and have been using estrogen-containing oral contraceptives must have discontinued the contraceptive product for at least 30 days before dosing, throughout the entire study period, and for 30 days after study drug discontinuation, and have been using use the aforementioned methods.
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for at least 90 days after the last dose of study drug.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
- Agents associated with thrombotic events (including oral contraceptives) are required to be discontinued 30 days prior to first study drug administration
- Evidence of organ dysfunction or any clinically significant deviation from normal in medical history, e.g., history of splenectomy
- History of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism)
- Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
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- Hemoglobin less than the lower limit of normal
- Clinically significant illness within 8 weeks, or a clinically significant infection within 4 weeks, of dosing
- Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline Periods 1 or 3
- A corrected QT interval using Fridericia's formula (QTcF) > 450 ms at Screening
- A known or suspected history of drug or alcohol misuse within 6 months before Screening, or a positive drug test at Screening or Baseline Periods 1 or 3
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C antibody (HCVAb) tests at Screening
- Receipt of blood products within 4 weeks, donation of blood within 8 weeks, or donation of plasma within 1 week before dosing
- Known history of clinically significant drug or food allergies or experiencing significant seasonal allergy (e.g., hay fever) or hypersensitivity to avatrombopag and/or any of its excipients
- Use of prescription drugs within 4 weeks or within five times the drug's half-life (if that time is >4 weeks) before Screening
- Participation in another clinical trial within 60 days before dosing or concurrent enrollment in another clinical trial
- Unwilling or unable to abide by the requirements of the study
- Any condition that would make them, in the opinion of the investigator, unsuitable for the study or who, in the opinion of the investigator, are not likely to complete the study for any reason
- Females who are pregnant (positive β-hCG test) or breastfeeding
- Hypersensitivity to aspirin
- Scheduled for surgery or other invasive procedure during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal.
- Conditions
- Healthy Volunteers
- Being tested
- Avatrombopag maleate 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatrombopag maleate 40 mgDrug
Also called E5501
Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base) given with 240 mL water in three single oral doses, one during each of three treatment periods. Participants randomized to one of three treatment sequences:
- Fed, Fed, Fasted; or
- Fed, Fasted, Fed; or
- Fasted, Fed, Fed
During the Fasted period, participants must have fasted for at least a 10-hour overnight fast and to refrain from eating for 4 hours.
During the Fed period, participants were allowed approximately 30 minutes to eat a low-fat breakfast and required to take the drug within 15 minutes of completion of breakfast.
Randomization Phase consists of three single-dose treatment periods:
Treatment Period 1 and 2 separated by a 7-day washout interval. Treatment Period 2 and 3 separated by a 28-day washout interval. Treatment period 3 and the Follow-up/ Termination Visit will be separated by a 30-day (+1 day) washout interval.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag maleate 40 mg | Experimental | Not described Receives: Drug: Avatrombopag maleate 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time course profile From Time = 0 to time extrapolated to infinity (AUC [0-inf])
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose
Maximum Observed Plasma Concentration (Cmax)
Measured: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Allison, MD, Principal investigator, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759394
- Sponsor's protocol ID
- E5501-A001-017
- Status last verified
- Oct 2013
- First submitted
- 6 Dec 2012
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
- ClinicalTrials.gov ID
- NCT01759394
- Acronym / sponsor ID
- E5501-A001-017
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Jan 2013 (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.
A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag maleate 40 mg | Experimental | Drug: Avatrombopag maleate 40 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female subjects (aged 18 to 55 years inclusive, at the time of informed consent)
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2 at Screening
- Platelet count between 120 x 109/L and 300 x 109/L inclusive at Screening, Baseline Period 1, or Baseline Period 3
- Platelet count below the upper limit of normal at Baseline Period 2
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity 25 IU/L or equivalent units of β-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Key exclusion criteria (21 listed)
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
- Agents associated with thrombotic events (including oral contraceptives) are required to be discontinued 30 days prior to first study drug administration
- Evidence of organ dysfunction or any clinically significant deviation from normal in medical history, e.g., history of splenectomy
- History of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism)
- Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
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 |
|---|---|---|
| Avatrombopag maleate 40 mgAlso: E5501Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base) given with 240 mL water in three single oral doses, one during each of three treatment periods. Participants randomized to one of three treatment sequences: * Fed, Fed, Fasted; or * Fed, Fasted, Fed; or * Fasted, Fed, Fed During the Fasted period, participants must have fasted for at least a 10-hour overnight fast and to refrain from eating for 4 hours. During the Fed period, participants were allowed approximately 30 minutes to eat a low-fat breakfast and required to take the drug within 15 minutes of completion of breakfast. Randomization Phase consists of three single-dose treatment periods: Treatment Period 1 and 2 separated by a 7-day washout interval. Treatment Period 2 and 3 separated by a 28-day washout interval. Treatment period 3 and the Follow-up/ Termination Visit will be separated by a 30-day (+1 day) washout interval. | Drug | Avatrombopag maleate 40 mg |
Primary outcome
Area under the plasma concentration-time course profile From Time = 0 to time extrapolated to infinity (AUC [0-inf])
Time frame: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)
Time frame: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose
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 31 Oct 2013.
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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.
Mark Allison, MD principal investigator
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 Avatrombopag maleate 40 mg in people with Healthy Volunteers, 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 12 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 31 Oct 2013. 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?
Area under the plasma concentration-time course profile From Time = 0 to time extrapolated to infinity (AUC [0-inf]) (time frame: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose). The study lists 2 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 31 Oct 2013.