Linked Life Data

20133508

Source:http://linkedlifedata.com/resource/pubmed/id/20133508

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
2010-6-17
pubmed:abstractText
This phase 1 study evaluated the single-dose pharmacokinetics and safety of subcutaneous golimumab, a human anti-tumor necrosis factor-alpha monoclonal antibody, in healthy Japanese and Caucasian subjects. Eligible subjects were males, aged 20 to 45 years, weighing 50 to 90 kg with a body mass index of 19 to 30 kg/m(2). Japanese and Caucasian subjects were matched by body weight and dose group. Blood samples were collected through day 50 following a single subcutaneous injection of golimumab 50 or 100 mg. The pharmacokinetic parameters were determined using a noncompartmental method. All 51 subjects (24 Japanese, 27 Caucasian) were included in the safety analysis; 47 completed the study and were included in the pharmacokinetic analysis. The pharmacokinetics of golimumab were comparable in both race groups. Peak concentrations were observed approximately 4 to 6 days after administration. No significant differences in exposure or mean half-life (range, 11-13 days) were observed between Japanese and Caucasian subjects at the same dose level. Regardless of race, serum golimumab exposure increased with increasing dose. Mean apparent clearance ranged from 12 to 19 mL/kg/d. Mean apparent volume of distribution (224-262 mL/kg) remained constant with an increase in dose. No antibodies to golimumab were detected. Single subcutaneous injections of golimumab 50 mg or 100 mg were generally well tolerated in these healthy male Japanese and Caucasian subjects.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
1552-4604
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
50
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
792-802
pubmed:meshHeading
pubmed-meshheading:20133508-Adult, pubmed-meshheading:20133508-Alanine Transaminase, pubmed-meshheading:20133508-Antibodies, pubmed-meshheading:20133508-Antibodies, Monoclonal, pubmed-meshheading:20133508-Area Under Curve, pubmed-meshheading:20133508-Asian Continental Ancestry Group, pubmed-meshheading:20133508-Aspartate Aminotransferases, pubmed-meshheading:20133508-Body Mass Index, pubmed-meshheading:20133508-Cohort Studies, pubmed-meshheading:20133508-Ethnic Groups, pubmed-meshheading:20133508-European Continental Ancestry Group, pubmed-meshheading:20133508-Half-Life, pubmed-meshheading:20133508-Humans, pubmed-meshheading:20133508-Injections, Subcutaneous, pubmed-meshheading:20133508-Japan, pubmed-meshheading:20133508-Male, pubmed-meshheading:20133508-Single-Blind Method, pubmed-meshheading:20133508-Young Adult
pubmed:year
2010
pubmed:articleTitle
Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects.
pubmed:affiliation
Pharmacokinetics, Modeling & Simulation, Clinical Pharmacology Sciences, Centocor Research and Development, Inc, C-4-5, 200 Great Valley Parkway, Malvern, PA 19355, USA. jling@its.jnj.com
pubmed:publicationType
Journal Article, Comparative Study, Randomized Controlled Trial, Clinical Trial, Phase I