| Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects. | |
| | |
MedLine Citation:
|
PMID: 20133508 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Jie Ling; Sally Lyn; Zhenhua Xu; Meguru Achira; Esther Bouman-Thio; Akira Shishido; Joyce Ford; Gopi Shankar; Carrie Wagner; Kenneth T Kim; Hugh M Davis; Honghui Zhou |
Related Documents
:
|
8578898 - Species specific pharmacokinetics of rolitetracycline. 9108638 - Intraindividual and interindividual variability in the disposition of the local anesthe... 18600318 - Absence of time-dependent artesunate pharmacokinetics in healthy subjects during 5-day ... 12242598 - Pharmacokinetics of mono-3'- and mono-4'-0-(beta-hydroxyethyl)-rutoside derivatives, af... 9581258 - The effects of high-dose methotrexate on the development of cartilage lesions in a lapi... 9426828 - Cartilage protective agent (cpa) ro 32-3555, a new matrix metalloproteinase inhibitor f... |
Publication Detail:
|
Type: Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial Date: 2010-02-04 |
Journal Detail:
|
Title: Journal of clinical pharmacology Volume: 50 ISSN: 1552-4604 ISO Abbreviation: J Clin Pharmacol Publication Date: 2010 Jul |
Date Detail:
|
Created Date: 2010-06-17 Completed Date: 2010-09-17 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 0366372 Medline TA: J Clin Pharmacol Country: United States |
Other Details:
|
Languages: eng Pagination: 792-802 Citation Subset: IM |
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 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adult Alanine Transaminase / blood Antibodies / analysis Antibodies, Monoclonal / administration & dosage, adverse effects, pharmacokinetics* Area Under Curve Asian Continental Ancestry Group Aspartate Aminotransferases / blood Body Mass Index Cohort Studies Ethnic Groups European Continental Ancestry Group Half-Life Humans Injections, Subcutaneous Japan Male Single-Blind Method Young Adult |
| Chemical | |
Reg. No./Substance:
|
0/Antibodies; 0/Antibodies, Monoclonal; 0/golimumab; EC 2.6.1.1/Aspartate Aminotransferases; EC 2.6.1.2/Alanine Transaminase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Population pharmacokinetics of liraglutide, a once-daily human glucagon-like peptide-1 analog, in he...
Next Document: CYP3A5 but not CYP2D6 polymorphism contributes significantly to the variability in dextropropoxyphen...