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This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in Mexican healthy volunteers under fasting conditions. The study will be an open label, single dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0 kg/meter (m)^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered trademark of the GSK group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag 50 mg | Experimental | Each volunteer will receive orally, single dose of tablet eltrombopag 50 mg under fasting conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Eltrombopag 50 mg per tablet for oral route of administration will be sourced locally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of PK parameters for eltrombopag | Following PK parameters will be assessed: Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC[0-t]), area under the curve (concentration/time) from time 0 extrapolated to infinity (AUC[0 inf]), maximum observed concentration (Cmax) and time to Cmax (tmax) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of adverse events (AEs) and Serious adverse events (SAEs) | AEs and SAEs will be collected from the screening until the follow-up visit | Up to Day 12 |
| Monitoring vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mexico City | 14610 | Mexico |
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| Label | URL |
|---|---|
| Results for study 200338 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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Vital signs assessments included temperature, systolic and diastolic blood pressure, and pulse rate measurements
| Up to Day 12 |
| Electrocardiograms (ECG) assessments | Single 12-lead ECGs will be obtained over a brief (eg, 5-10 minute) recording period at each study visit. | Up to Day 12 |
| Clinical laboratory parameters | Clinical laboratory parameters will include hematology, clinical chemistry and urine analysis | Up to Day 12 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |