Source:http://linkedlifedata.com/resource/pubmed/id/20418510
Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
3
|
| pubmed:dateCreated |
2011-2-25
|
| pubmed:abstractText |
This was a double-blind, placebo-controlled, randomized, parallel, dose-escalation study to assess the pharmacokinetics, platelet response, safety, and tolerability of supratherapeutic doses of eltrombopag (100 mg, 150 mg, and 200 mg once daily) administered for 5 days to 33 healthy adult volunteers. Plasma eltrombopag concentrations accumulated between days 1 and 5, with average increases of 66% to 81% for area under the plasma concentration-time curve from time zero to the end of the 24-hour dosing interval (AUC(0-?)) and 32% to 45% for maximum observed plasma concentration (C(max)) across doses. After 5 days of dosing, AUC(0-?) was dose-proportional and C(max) was less than dose-proportional over eltrombopag 100 to 200 mg with slope estimates (90% confidence intervals) of 0.92 (0.45-1.39) and 0.76 (0.29-1.22), respectively. Platelet counts peaked at day 14, and maximum change from baseline platelet count increased dose-dependently, with mean platelet count increases of 14, 67, 107, and 150 Gi/L for placebo and eltrombopag 100 mg, 150 mg, and 200 mg, respectively. There was no notable difference in day 14 mean platelet aggregation between eltrombopag (59 to 74%) and placebo (67%), although this was not tested statistically. There was no notable difference in adverse event frequency across eltrombopag doses. Eltrombopag pharmacokinetics and platelet response were dose-dependent, and doses up to 200 mg/d were well tolerated, with safety profiles similar to placebo.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Benzoic Acids,
http://linkedlifedata.com/resource/pubmed/chemical/Hematologic Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Hydrazines,
http://linkedlifedata.com/resource/pubmed/chemical/Pyrazoles,
http://linkedlifedata.com/resource/pubmed/chemical/Receptors, Thrombopoietin,
http://linkedlifedata.com/resource/pubmed/chemical/eltrombopag
|
| pubmed:status |
MEDLINE
|
| pubmed:month |
Mar
|
| pubmed:issn |
1552-4604
|
| pubmed:author | |
| pubmed:issnType |
Electronic
|
| pubmed:volume |
51
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
301-8
|
| pubmed:meshHeading |
pubmed-meshheading:20418510-Adult,
pubmed-meshheading:20418510-Area Under Curve,
pubmed-meshheading:20418510-Benzoic Acids,
pubmed-meshheading:20418510-Dose-Response Relationship, Drug,
pubmed-meshheading:20418510-Double-Blind Method,
pubmed-meshheading:20418510-Female,
pubmed-meshheading:20418510-Hematologic Agents,
pubmed-meshheading:20418510-Humans,
pubmed-meshheading:20418510-Hydrazines,
pubmed-meshheading:20418510-Male,
pubmed-meshheading:20418510-Middle Aged,
pubmed-meshheading:20418510-Platelet Aggregation,
pubmed-meshheading:20418510-Platelet Count,
pubmed-meshheading:20418510-Pyrazoles,
pubmed-meshheading:20418510-Receptors, Thrombopoietin,
pubmed-meshheading:20418510-Reproducibility of Results,
pubmed-meshheading:20418510-Thrombocytopenia,
pubmed-meshheading:20418510-Thrombopoiesis,
pubmed-meshheading:20418510-Time Factors,
pubmed-meshheading:20418510-Young Adult
|
| pubmed:year |
2011
|
| pubmed:articleTitle |
Clinical pharmacokinetics, platelet response, and safety of eltrombopag at supratherapeutic doses of up to 200 mg once daily in healthy volunteers.
|
| pubmed:affiliation |
GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
|
| pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Multicenter Study
|