Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Tytuł pozycji:

Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.

Tytuł:
Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Autorzy:
Li C; Phase 1 Clinical Trial Unit, First Hospital, Jilin University, Changchun, Jilin, China.
Li X; Phase 1 Clinical Trial Unit, First Hospital, Jilin University, Changchun, Jilin, China.
Zhu X; Phase 1 Clinical Trial Unit, First Hospital, Jilin University, Changchun, Jilin, China.
Zhang H; Phase 1 Clinical Trial Unit, First Hospital, Jilin University, Changchun, Jilin, China.
Shen G; Gilead Sciences Inc, Foster City, CA, USA.
Kersey K; Gilead Sciences Inc, Foster City, CA, USA.
Ding Y; Phase 1 Clinical Trial Unit, First Hospital, Jilin University, Changchun, Jilin, China. Electronic address: .
Źródło:
Clinical therapeutics [Clin Ther] 2020 Mar; Vol. 42 (3), pp. 448-457. Date of Electronic Publication: 2020 Feb 27.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Publication: 1998- : Belle Mead, NJ, : Excerpta Medica
Original Publication: Princeton, N. J., Excerpta Medica.
MeSH Terms:
Antiviral Agents*/adverse effects
Antiviral Agents*/blood
Antiviral Agents*/pharmacokinetics
Benzimidazoles*/adverse effects
Benzimidazoles*/blood
Benzimidazoles*/pharmacokinetics
Carbamates*/adverse effects
Carbamates*/blood
Carbamates*/pharmacokinetics
Fluorenes*/adverse effects
Fluorenes*/blood
Fluorenes*/pharmacokinetics
Heterocyclic Compounds, 4 or More Rings*/adverse effects
Heterocyclic Compounds, 4 or More Rings*/blood
Heterocyclic Compounds, 4 or More Rings*/pharmacokinetics
Sofosbuvir*/adverse effects
Sofosbuvir*/blood
Sofosbuvir*/pharmacokinetics
Adult ; China ; Female ; Humans ; Male
Contributed Indexing:
Keywords: chinese; hepatitis C virus; ledipasvir; pharmacokinetics; sofosbuvir; velpatasvir
Substance Nomenclature:
0 (Antiviral Agents)
0 (Benzimidazoles)
0 (Carbamates)
0 (Fluorenes)
0 (Heterocyclic Compounds, 4 or More Rings)
013TE6E4WV (ledipasvir)
KCU0C7RS7Z (velpatasvir)
WJ6CA3ZU8B (Sofosbuvir)
Entry Date(s):
Date Created: 20200303 Date Completed: 20201015 Latest Revision: 20201015
Update Code:
20240105
DOI:
10.1016/j.clinthera.2020.01.013
PMID:
32115243
Czasopismo naukowe
Purpose: Ledipasvir/sofosbuvir and sofosbuvir/velpatasvir have been approved worldwide for the treatment of chronic hepatitis C virus (HCV) infection. Although both have been approved in China, there are currently no data on their pharmacokinetic profiles in Chinese individuals. Two studies investigated the pharmacokinetic properties, safety, and tolerability of ledipasvir/sofosbuvir and sofosbuvir/velpatasvir, respectively, in healthy Chinese subjects.
Methods: Two Phase I, open-label, single- and multiple-dose studies were conducted in healthy Chinese subjects. Ledipasvir/sofosbuvir (90/400 mg) or sofosbuvir/velpatasvir (400/100 mg), respectively, was administered orally once daily under fasted conditions. Subjects received a single dose (day 1) and multiple doses (days 8-17 [ledipasvir/sofosbuvir]; days 8-14 [sofosbuvir/velpatasvir]). Plasma pharmacokinetic parameters were estimated by using noncompartmental models, and safety was assessed through clinical evaluation and monitoring of adverse events.
Findings: Fourteen subjects were enrolled in each study (7 men, 7 women each; mean age, 30 years [ledipasvir/sofosbuvir] and 29 years [sofosbuvir/velpatasvir]). The pharmacokinetic parameters for sofosbuvir, GS-566500, GS-331007, and ledipasvir or velpatasvir were similar to historical values in non-Chinese subjects. Consistent with the t 1/2 of ledipasvir relative to 24-h dosing, accumulation of 177% (AUC) and 107% (C max ) was observed. There was no significant accumulation of velpatasvir, sofosbuvir, GS-566500, or GS-331007. Both drugs were generally well tolerated; no serious adverse events or discontinuations due to adverse events were reported.
Implications: Overall, ledipasvir/sofosbuvir and sofosbuvir/velpatasvir exhibited pharmacokinetic and safety profiles in healthy Chinese subjects similar to those in non-Chinese subjects in historical studies, supporting their use in the Chinese population with HCV infection. ChinaDrugTrials.org.cn identifiers: CTR20160149 (ledipasvir/sofosbuvir); CTR20160602 (sofosbuvir/velpatasvir).
(Copyright © 2020 Elsevier Inc. All rights reserved.)

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies