- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072162
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect
November 10, 2017 updated by: GlaxoSmithKline
A Randomized, Open-label, Five-period, Balanced Crossover Study to Evaluate the Relative Bioavailability of an Eltrombopag Powder for Oral Suspension (PfOS) Formulation Relative to the Commercial 25 mg Tablet Formulation and to Evaluate Administration of the PfOS Formulation With and Separated 2 Hours From a High Calcium Meal in Healthy Adult Subjects
This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA.
Subjects receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose.
There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit.
During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations.
Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA.
Subjects receive five eltrombopag treatments: tablet fasted, PfOS fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose.
There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit.
During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations.
Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Buffalo, New York, United States, 14202
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
- Male and female subjects between the ages of 18 to 64 years of age inclusive, at the time of signing the informed consent.
- Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
- Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the consent form.
- Body weight ≥ 50kg (110 lbs) for men and ≥ 45 kg (99 lbs) for women and body mass index (BMI) of 18.5 to 29.9 kg/m2 inclusive.
- A platelet count within normal range and not > 400,000 plt/uL.
- Male subjects, who are not surgically sterile, must agree on abstinence or to use a double barrier method, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository). This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of medication.
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories:
- non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females defined as being amenorrheic for greater than one year and having serum estradiol and follicle stimulating hormone levels consistent with menopause.
- child-bearing potential with negative beta human chorionic gonadotropin (beta/hCG) test and agrees to comply with recognized non-hormonal contraceptive methods from screening or at least two weeks prior to first dose (whichever is earlier) until the follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, male partner sterilization, two forms of barrier contraception (e.g. condom and occlusive cap (diaphragm or cervical/vault caps with spermicide), or intrauterine device (IUD), or intrauterine system (IUS) with a < 1% failure rate stated in the product label.
Exclusion Criteria:
- History of Gilbert's syndrome.
- Any previous history of deep vein thrombosis or any other thromboembolic event.
- History of thrombocytopenia or bleeding due to abnormal platelet number or function.
- Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
- Elevated blood pressure (BP) at screening (systolic > 140 mm Hg, diastolic > 85 mm Hg). If the subject's BP is elevated on the first measurement, complete two additional BP measurements two minutes apart and average the three assessments to evaluate this criteria. If averaged BP exceeds the safety criteria, the subject should be excluded.
- History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
- Prolonged QTc interval (Bazett's) at screening (for females > 450 msec and for males > 430 msec). If the QTc interval is prolonged on the initial ECG, then complete two additional ECGs 5 minutes apart and take the average QTc measurements of all three ECGs to evaluate this criteria. If averaged QTc exceeds the safety criteria, the subject should be excluded.
- Female subjects currently receiving hormone replacement therapy (HRT).
- Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
- Positive urine drug screen including alcohol at screening or pre-dose (Day -1).
- History of alcohol/drug abuse or dependence within 12 months of the study.
- History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
- Urinary cotinine levels indicative of smoking at screening or pre-dose (Day -1). History of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs (including aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]), vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or five half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Subjects who have donated plasma within seven days prior to the screening visit or where participation in this study would result in donation of blood in excess of 500 mL within a 56-day period.
- History of sensitivity to any of the study medications, or components thereof.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm B
25 mg powder for oral suspension single dose fasted.
|
25 mg tablet
25 mg powder for oral suspension
|
EXPERIMENTAL: Arm C
25 mg powder for oral suspension administered with a meal
|
25 mg tablet
25 mg powder for oral suspension
|
EXPERIMENTAL: Arm D
25 mg powder for oral suspension administered 2 hours prior to meal
|
25 mg tablet
25 mg powder for oral suspension
|
EXPERIMENTAL: Arm E
25 mg powder for oral suspension administered 2 hours after to meal
|
25 mg tablet
25 mg powder for oral suspension
|
OTHER: Arm A
Commercially available eltrombopag 25 mg tablet
|
25 mg tablet
25 mg powder for oral suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the relative bioavailability of a PfOS formulation relative to the commercial eltrombopag 25 mg tablet formulation in healthy adult subjects.
Time Frame: 72 hours x 2 periods
|
72 hours x 2 periods
|
Evaluate the effect of a high calcium, moderate fat and calorie meal on the pharmacokinetics of a single oral 25 mg dose of eltrombopag PfOS in healthy adult subjects when eltrombopag is administered concurrently, two hours before, or two hours afte
Time Frame: 72 hours x 3 periods
|
72 hours x 3 periods
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the safety and tolerability of single oral doses of eltrombopag.
Time Frame: 12-14 weeks
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12-14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 12, 2010
Primary Completion (ACTUAL)
April 7, 2010
Study Completion (ACTUAL)
April 7, 2010
Study Registration Dates
First Submitted
February 12, 2010
First Submitted That Met QC Criteria
February 18, 2010
First Posted (ESTIMATE)
February 19, 2010
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- 111718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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