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Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study
The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once‐daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292889/ https://www.ncbi.nlm.nih.gov/pubmed/32945153 http://dx.doi.org/10.1002/cpdd.868 |
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author | Zhao, Xia Sheng, Xiao Yan Payne, Christopher D. Zhang, Xin Wang, Feng Cui, Yi Min |
author_facet | Zhao, Xia Sheng, Xiao Yan Payne, Christopher D. Zhang, Xin Wang, Feng Cui, Yi Min |
author_sort | Zhao, Xia |
collection | PubMed |
description | The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once‐daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through 10 for 7 consecutive days (multiple doses). Plasma pharmacokinetic samples were collected up to 48 hours after dosing on days 1 and 10, with predose samples collected before dosing on day 1 and days 4 through 10. Safety and tolerability were also assessed. Baricitinib was rapidly absorbed, reaching peak plasma concentrations within 0.5 to 1 hour (median). Plasma concentrations declined rapidly following the attainment of peak concentrations, with a mean terminal half‐life of 5.7 to 7.3 hours. Steady‐state plasma concentrations of baricitinib were achieved after the second day of once‐daily dosing, with minimal accumulation of baricitinib in plasma (up to 10% increase in area under the plasma concentration–time curve). Single‐ and multiple‐dose mean values for area under the plasma concentration–time curve from time zero to infinity and maximum plasma concentration appeared to increase in an approximately dose‐proportional manner across the dose range. Single and multiple oral doses of once‐daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects. |
format | Online Article Text |
id | pubmed-9292889 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92928892022-07-20 Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study Zhao, Xia Sheng, Xiao Yan Payne, Christopher D. Zhang, Xin Wang, Feng Cui, Yi Min Clin Pharmacol Drug Dev Articles The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once‐daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through 10 for 7 consecutive days (multiple doses). Plasma pharmacokinetic samples were collected up to 48 hours after dosing on days 1 and 10, with predose samples collected before dosing on day 1 and days 4 through 10. Safety and tolerability were also assessed. Baricitinib was rapidly absorbed, reaching peak plasma concentrations within 0.5 to 1 hour (median). Plasma concentrations declined rapidly following the attainment of peak concentrations, with a mean terminal half‐life of 5.7 to 7.3 hours. Steady‐state plasma concentrations of baricitinib were achieved after the second day of once‐daily dosing, with minimal accumulation of baricitinib in plasma (up to 10% increase in area under the plasma concentration–time curve). Single‐ and multiple‐dose mean values for area under the plasma concentration–time curve from time zero to infinity and maximum plasma concentration appeared to increase in an approximately dose‐proportional manner across the dose range. Single and multiple oral doses of once‐daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects. John Wiley and Sons Inc. 2020-09-17 2020 /pmc/articles/PMC9292889/ /pubmed/32945153 http://dx.doi.org/10.1002/cpdd.868 Text en © 2020 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Zhao, Xia Sheng, Xiao Yan Payne, Christopher D. Zhang, Xin Wang, Feng Cui, Yi Min Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title | Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title_full | Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title_fullStr | Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title_full_unstemmed | Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title_short | Pharmacokinetics, Safety, and Tolerability of Single‐ and Multiple‐Dose Once‐Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo‐Controlled Study |
title_sort | pharmacokinetics, safety, and tolerability of single‐ and multiple‐dose once‐daily baricitinib in healthy chinese subjects: a randomized placebo‐controlled study |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292889/ https://www.ncbi.nlm.nih.gov/pubmed/32945153 http://dx.doi.org/10.1002/cpdd.868 |
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