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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00833378 |
This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag with LPV/RTV on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs.
Condition | Intervention | Phase |
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Thrombocytopenia |
Drug: Eltrombopag and Lopinavir/Ritonavir Drug: Lopinavir/Ritonavir Drug: Eltrombopag |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open-Label, Single Sequence, Crossover Study Evaluating the Safety and the Pharmacokinetics of Lopinavir/Ritonavir and Eltrombopag Given Alone and When Co-Administered in Healthy Adult Subjects. |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Period 2: Active Comparator
Treatment B
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Drug: Lopinavir/Ritonavir
Lopinavir/Ritonavir 400/100 mg oral dose given twice a day for 14 days
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Period 3: Active Comparator
Treatment C
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Drug: Eltrombopag and Lopinavir/Ritonavir
Elrombopag 100 mg single oral dose and Lopinavir/Ritonavir 400/100 mg oral dose given in the AM and PM
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Period 1: Active Comparator
Treatment A
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Drug: Eltrombopag
Eltrombopag 100 mg single oral dose
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories:
Exclusion Criteria:
Any previous history of deep vein thrombosis or any other thromboembolic event. 3. History of thrombocytopenia or bleeding due to abnormal platelet number or function. 4. Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency. 5. 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 2 minutes apart and average the three assessments to evaluate this criteria. If averaged BP exceeds the safety criteria, the subject should be excluded.
6. History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit. 7. 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. 8. Female subjects currently receiving hormone replacement therapy (HRT). 9. Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
10. Positive urine drug screen including alcohol at screening or pre-dose (Day -1).
11. History of alcohol/drug abuse or dependence within 12 months of the study. RM2008/00650/00 CONFIDENTIAL TPL111716 25 CONFIDENTIAL RM2008/00650/00 TPL111716 26 12. 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). 13. 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. 14. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. 15. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 16. Use of prescription or non-prescription drugs (including aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]), vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or 5 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. 17. Subjects who have donated plasma within 7 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. 18. History of sensitivity to any of the study medications, or components thereof.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, New York | |
GSK Investigational Site | |
Buffalo, New York, United States, 14202 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111716 |
Study First Received: | January 29, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00833378 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug interaction, SB-497115 (eltrombopag), Kaletra (Lopinavir, Ritonavir),thrombocytopenia, pharmacokinetics |
Thrombocytopathy HIV Protease Inhibitors Anti-HIV Agents Thrombocytopenia Anti-Retroviral Agents Lopinavir |
Ritonavir Hematologic Diseases Blood Platelet Disorders Healthy Antiviral Agents Protease Inhibitors |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Hematologic Diseases Blood Platelet Disorders Enzyme Inhibitors Antiviral Agents |
Pharmacologic Actions Protease Inhibitors Thrombocytopenia Lopinavir Anti-Retroviral Agents Ritonavir Therapeutic Uses |