A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02254434
• Date of registration: 29/09/2014
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions
• Scientific title: An Open-label Single-dose Pharmacokinetic Study of an Oral Formulation in Tablets Containing Eltrombopag 50 mg (Revolade, Glaxosmithkline Mexico, S.A. De C.V.) in Healthy Volunteers Under Fasting Conditions
• Date of first enrolment: August 28, 2014
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254434
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Mexico

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects' participation must be voluntary according to the General Health Law and an
informed consent form must be obtained for each subject before their participation.
Compliance to Helsinki´s Declaration, its Japan Review and good clinical practice
(GCP) should be followed.

- Mexican male and female healthy volunteers with 18 to 50 years old will be included. A
female subject is eligible to participate if she is of, Non-childbearing potential
defined as pre menopausal females with a documented tubal ligation or hysterectomy
(for this definition, "documented" refers to the outcome of the
investigator's/designee's review of the subject's medical history for study
eligibility, as obtained via a verbal interview with the subject or from the subject's
medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH]
> 40 milliinternational units per milliliter (MlU/ml) and estradiol < 40 picogram per
milliliter [pg/ml] [<147 picomole per liter (pmol/L)] is confirmatory). Females on
hormone replacement therapy (HRT) and whose menopausal status is in doubt will be
required to use one of the contraception methods as described by the
Investigator/designee, if they wish to continue their HRT during the study. Otherwise,
they must discontinue HRT to allow confirmation of post-menopausal status prior to
study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the
cessation of therapy and the blood draw; this interval depends on the type and dosage
of HRT. Following confirmation of their post-menopausal status, they can resume use of
HRT during the study without use of a contraceptive method). Child-bearing potential
with negative pregnancy test as determined by (serum or urine) human chorionic
gonadotropin (hCG) test at screening or prior to dosing abbr de ante meridiem (AN ).
Agrees to use one of the contraception methods listed by Investigator/designee for an
appropriate period of time (as determined by the product label or investigator) prior
to the start of dosing to sufficiently minimize the risk of pregnancy at that point.
Female subjects must agree to use contraception until seven days after the drug
administration. or has only same-sex partners, when this is her preferred and usual
lifestyle.

- Body mass index (BMI) between 18-27.0 kilogram per meter (kg/m^2) according to
Quetelet.

- Volunteers should be healthy as determined by their medical evaluation done by the
physicians in the center and by their safety labs results done at a certified local
laboratory.

- Variation limits within normal ranges on their screening visit are: Blood pressure
(BP) (seating) between 90 and 130 millimeters of mercury (mm Hg) for Systolic pressure
and between 60 and 90 mmHg diastolic pressure, heart rate (HR) between 55 and 100
beats per minute (bpm) and respiratory rate (RR) between 14 and 20 per minute.

- Safety laboratory tests to be done include: Hematology: Complete blood count with
differential, Hemoglobin, Hematocrit, platelet count, etc; Blood chemistry: Albumin,
Alkaline phosphatase, aspartate-aminotransferase (AST), alanine aminotransferase
(ALT), Urea, Calcium, Chloride, Glucose, Phosphate, Potassium, Serum creatinine,
Sodium, Total bilirubin, Total protein, etc; Urinalysis: pH, Specific gravity,
Protein, Glucose, Ketones, Bilirubin, Occult blood and cells, Nitrite, Urobilinogen,
Leukocytes, Microscopic examination; Hepatitis B and C tests; human Immunodeficiency
Virus (HIV) test; Serum pregnancy test; Drug abuse test; Alcohol detection test; Urine
Pregnancy test; ECG; Chest X ray. Normal variation limits for laboratory values will
be +/- 10% from normal range, unless the principal investigator (PI) considers another
deviation as clinically non-significant. In that case, values should be documented in
the volunteer's clinical file as well as the decision to include the subject prior
consult with GlaxoSmithKline (GSK) Medical Monitor. For safety reasons and as per the
PI criteria additional ECG or safety labs may be performed.

Exclusion Criteria:

- Subjects with changes on their vital signs compared to what obtained in the screening
visit.

- Volunteers that not comply with all the inclusion criteria described previously

- Volunteers with history of clinically relevant cardiovascular, renal, hepatic,
muscular, metabolic. Clinically relevant hematologic, gastrointestinal, neurological,
endocrine, pulmonary, mental disease or any other organical abnormality. Volunteers
with muscular traumatism within 21 days before the study.

- Volunteers that require any drug during the study, besides the study drug.

- Volunteers with dyspepsia, gastritis, esofagitis, duodenal o gastric ulcers.

- Volunteers that have received hepatic metabolism drug inhibitors or inducers within 30
days of the beginning of the study and that have received drugs that may alter urinary
pH, like antiacids with sodium bicarbonate, potasium citrate and certain diuretics

- Volunteers who received any drug and that 7 half lives have not been completed at the
beginning of the study.

- Volunteers who have ALT, alkaline phosphatase and bilirubin <= 1.5x upper limit of
normal range (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is
fractionated and direct bilirubin <35%).

- Corrected QT interval duration (QTc) values of triplicate ECGs obtained over a brief
recording period: QTc < 450 milliseconds (msec); or QTc < 480 msec in subjects with
Bundle Branch Block.

- Volunteers that might have required to be hospitalized for any reason within 6 months
before the beginning of the study

- Subjects with a previous participation in another research study within 60 days prior
to the beginning of the study.

- Subjects allergic to any food, drug and/or substance

- Subjects with known history of sensitivity to heparin or heparin-induced
thrombocytopenia.

- Subjects who consume alcohol, coffee, grapefruit, nicotine, orange or metilxantines
containing substances (coffee, tea, chocolate, cola products, broiled products etc)
within 72 hours prior to their confinement period and until the end of the study.

- Subjects that might have lost or donated 450 ml of blood within the 60 days prior to
the beginning of the study.

- Alcohol or drug abuse history

- Volunteers who require special meals (vegetarian).




Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cirrhosis, Liver

Intervention(s)

Drug: Eltrombopag

Primary Outcome(s)

Composite of PK parameters for eltrombopag [Time Frame: Serum Pharmacokinetic (PK) samples will be collected pre-dose and then samples will be obtained 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12, 16, 24, 48, 72 and 96 hours after drug administration]

Secondary Outcome(s)

Monitoring vital signs [Time Frame: Up to Day 12]

Electrocardiograms (ECG) assessments [Time Frame: Up to Day 12]

Clinical laboratory parameters [Time Frame: Up to Day 12]

Incidence and nature of adverse events (AEs) and Serious adverse events (SAEs) [Time Frame: Up to Day 12]

Secondary ID(s)

200338

Source(s) of Monetary Support

Please refer to primary and secondary sponsors