Effect of Mild and Moderate Hepatic Impairment on Azimilide Pharmacokinetics Following Single Dose Oral Administration

2004 ◽  
Vol 93 (5) ◽  
pp. 1279-1286 ◽  
Author(s):  
Alfred E. Corey ◽  
Jeffrey R. Agnew ◽  
Eileen C. King ◽  
Nikhil J. Parekh ◽  
James H. Powell ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Hepatic Impairment ◽  
Moderate Hepatic Impairment ◽  
Dose Oral

scholarly journals Influence of hepatic impairment on lenvatinib pharmacokinetics following single‐dose oral administration

2014 ◽  
Vol 55 (3) ◽  
pp. 317-327 ◽  
Author(s):  
Robert Shumaker ◽  
Jagadeesh Aluri ◽  
Jean Fan ◽  
Gresel Martinez ◽  
Helen Pentikis ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Hepatic Impairment ◽  
Dose Oral

scholarly journals The concentrations of clarithromycin and its 14-hydroxy metabolite in sputum of patients with bronchiectasis following single dose oral administration

1994 ◽  
Vol 33 (2) ◽  
pp. 289-297 ◽  
Author(s):  
K. W. T. Tsang ◽  
P. Roberts ◽  
R. C. Read ◽  
F. Kees ◽  
R. Wilson ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Dose Oral ◽  
Hydroxy Metabolite

Pharmacokinetics of chlordesmethyldiazepam after single-dose oral administration in humans

1986 ◽  
Vol 11 (3) ◽  
pp. 171-174 ◽  
Author(s):  
S. R. Bareggi ◽  
R. Pirola ◽  
S. eva ◽  
L. Zecca
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Dose Oral

Toxicoklnetic of bifenox in goats after single dose oral administration

1998 ◽  
Vol 95 ◽  
pp. 143
Author(s):  
T.K. Mandal ◽  
S. Roy ◽  
A.K. Chakraborty ◽  
A. Bhattacharyya ◽  
A. Chowdhury
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Dose Oral

Brompheniramine and Chlorpheniramine Pharmacokinetics Following Single-Dose Oral Administration in Children Aged 2 to 17 Years

2017 ◽  
Vol 58 (4) ◽  
pp. 494-503 ◽  
Author(s):  
Sudam Pathirana ◽  
Shyamalie Jayawardena ◽  
Suzanne Meeves ◽  
Gary A. Thompson
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Dose Oral

scholarly journals Single-dose pharmacokinetics of BMS-986177/JNJ-70033093 in participants with mild or moderate hepatic impairment compared to healthy participants

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Perera ◽  
G Abelian ◽  
D Li ◽  
Z Wang ◽  
L Zhang ◽  
...  
Keyword(s):  
Single Dose ◽  
Hepatic Impairment ◽  
Hepatic Function ◽  
Moderate Hepatic Impairment ◽  
Funding Source ◽  
Antithrombotic Agents ◽  
Normal Hepatic Function ◽  
Pugh Class ◽  
Healthy Participants ◽  
Mild Hepatic Impairment

Abstract Background According to the scientific evidence accumulated to date (ie, genetic, epidemiological, preclinical, clinical), the modulation of Factor XI (FXI) function may provide a novel mechanism for systemic anticoagulation without increasing the risk of clinically significant bleeding in a variety of conditions predisposing patients to a high risk of thrombotic or bleeding events. BMS-986177/JNJ-70033093 (BMS-177/JNJ-3093) is a small molecule that inhibits the active form of FXI (FXIa) with high affinity and selectivity. Depending on the indication, BMS-177/JNJ-3093 may provide benefit to patients as add-on or potentially replacement therapy to the current standard of care antithrombotic agents. Patients with hepatic impairment may have an increased risk of bleeding when using existing antithrombotic agents and therefore may benefit from drugs with an improved safety profile. Purpose To assess the effect of mild or moderate hepatic impairment on the pharmacokinetic (PK) properties of BMS-177/JNJ-3093. Methods This was a multicenter, open-label, non-randomized, single-dose study. A single 60-mg oral dose of BMS-177/JNJ-3093 was administered to 9 participants with mild hepatic impairment (Child-Pugh class A), 8 participants with moderate hepatic impairment (Child-Pugh class B), and 9 healthy participants with normal hepatic function. Healthy participants were matched to participants with hepatic impairment in each Child-Pugh class with regard to body weight. To assess the effects of hepatic impairment on BMS-177/JNJ-3093 PK, an analysis of variance was performed on the natural log-transformed Cmax, AUC(INF), and AUC(0-T) with hepatic function group as a fixed effect. Results BMS-177/JNJ-3093 was well tolerated when administered as an oral dose of 60 mg in participants with mild or moderate hepatic impairment and healthy participants with normal hepatic function. There were no deaths, serious adverse events (AEs), severe AEs, bleeding AEs, or discontinuations due to an AE reported during the study. The geometric mean ratios (GMRs) (90% CI) comparing mild hepatic impairment to normal hepatic function were 1.180 (0.735, 1.895) and 1.168 (0.725, 1.882) for total BMS-177/JNJ-3093 maximum concentration (Cmax) and area under the curve from time 0 to infinity (AUC(INF)), respectively. The GMRs (90% CI) comparing moderate hepatic impairment to normal hepatic function were 1.140 (0.699, 1.857) and 0.996 (0.609, 1.628) for total BMS-177/JNJ-3093 Cmax and AUC(INF), respectively. Overall, levels of activated partial thromboplastin time (aPTT) increased in an exposure-related manner following single oral doses of 60 mg BMS-177/JNJ-3093 in all groups. Conclusion BMS-177/JNJ-3093 was well tolerated in the normal healthy participants and those with mild or moderate hepatic impairment. The observed changes indicate that a dose adjustment in these populations may not be necessary. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This work was sponsored by Bristol-Myers Squibb and Janssen Research & Development, LLC

scholarly journals Pharmacokinetics and Safety of Single-Dose Esaxerenone in Japanese Subjects with Mild to Moderate Hepatic Impairment

2019 ◽  
Vol 37 (1) ◽  
pp. 253-264 ◽  
Author(s):  
Akifumi Kurata ◽  
Takafumi Yoshida ◽  
Megumi Inoue ◽  
Tomoko Ishizuka ◽  
Takafumi Nakatsu ◽  
...  
Keyword(s):  
Single Dose ◽  
Hepatic Impairment ◽  
Moderate Hepatic Impairment ◽  
Japanese Subjects

Plasma Levels of the Prodrug, Arbaprostil, [(15R)-15-Methylprostaglandin E2], and its Active, Antiulcer (15S) Epimer in Humans after Single Dose Oral Administration

1986 ◽  
Vol 75 (11) ◽  
pp. 1107-1112 ◽  
Author(s):  
J.W. Cox ◽  
W.M. Bothwell ◽  
R.H. Pullen ◽  
M.A. Wynalda ◽  
F.A. Fitzpatrick ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Plasma Levels ◽  
Dose Oral
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