A phase-1, open-label, single-dose study of the pharmacokinetics of buparlisib in subjects with mild to severe hepatic impairment

Denes Csonka; Katharine Hazell; Edward Waldron; Sebastien Lorenzo; Vincent Duval; Lucia Trandafir; Zhanna D. Kobalava

doi:10.1002/jcph.590

A phase-1, open-label, single-dose study of the pharmacokinetics of buparlisib in subjects with mild to severe hepatic impairment

The Journal of Clinical Pharmacology ◽

10.1002/jcph.590 ◽

2015 ◽

Vol 56 (3) ◽

pp. 316-323 ◽

Cited By ~ 4

Author(s):

Denes Csonka ◽

Katharine Hazell ◽

Edward Waldron ◽

Sebastien Lorenzo ◽

Vincent Duval ◽

...

Keyword(s):

Single Dose ◽

Hepatic Impairment ◽

Phase 1 ◽

Severe Hepatic Impairment ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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A phase 1, open-label, single-dose study of the pharmacokinetics of zanubrutinib in subjects with varying degrees of hepatic impairment

Leukemia & Lymphoma ◽

10.1080/10428194.2020.1719097 ◽

2020 ◽

Vol 61 (6) ◽

pp. 1355-1363

Author(s):

Ying C. Ou ◽

Richard A. Preston ◽

Thomas C. Marbury ◽

Zhiyu Tang ◽

William Novotny ◽

...

Keyword(s):

Single Dose ◽

Hepatic Impairment ◽

Phase 1 ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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Absorption, Distribution, and Excretion of the Investigational Agent Orteronel (TAK-700) in Healthy Male Subjects: A Phase 1, Open-Label, Single-Dose Study

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.234 ◽

2016 ◽

Vol 5 (3) ◽

pp. 180-187

Author(s):

Ajit Suri ◽

Sandeepraj Pusalkar ◽

Yuexian Li ◽

Shimoga Prakash

Keyword(s):

Single Dose ◽

Phase 1 ◽

Healthy Male ◽

Open Label ◽

Single Dose Study ◽

Investigational Agent ◽

Dose Study ◽

Male Subjects

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Influence of Hepatic Impairment on the Pharmacokinetics and Safety Profile of Dapagliflozin: An Open-Label, Parallel-Group, Single-Dose Study

Clinical Therapeutics ◽

10.1016/j.clinthera.2011.09.011 ◽

2011 ◽

Vol 33 (11) ◽

pp. 1798-1808 ◽

Cited By ~ 47

Author(s):

Sreeneeranj Kasichayanula ◽

Xiaoni Liu ◽

Weijiang Zhang ◽

Marc Pfister ◽

Frank P. LaCreta ◽

...

Keyword(s):

Single Dose ◽

Safety Profile ◽

Hepatic Impairment ◽

Open Label ◽

Single Dose Study ◽

Parallel Group ◽

Dose Study

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An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis

International Journal of Antimicrobial Agents ◽

10.1016/j.ijantimicag.2015.09.009 ◽

2015 ◽

Vol 46 (6) ◽

pp. 682-688 ◽

Cited By ~ 2

Author(s):

Maria Sunzel ◽

Maria Learoyd ◽

Jianguo Li ◽

Yan Li ◽

Ngoc Ngo ◽

...

Keyword(s):

Single Dose ◽

Renal Disease ◽

End Stage Renal Disease ◽

Phase 1 ◽

Open Label ◽

Single Dose Study ◽

Intermittent Haemodialysis ◽

Dose Study ◽

Stage Renal Disease ◽

End Stage

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A phase 1, randomised, open-label, four-period crossover, single-dose study to evaluate the pharmacokinetics of hydrocortisone modified release tablets

Endocrine Abstracts ◽

10.1530/endoabs.37.ep54 ◽

2015 ◽

Author(s):

Gudmundur Johannsson ◽

Hans Lennernas ◽

Claudio Marelli ◽

Kevin Rockich ◽

Stanko Skrtic

Keyword(s):

Single Dose ◽

Phase 1 ◽

Modified Release ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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Pharmacokinetics of aclidinium bromide/formoterol fumarate fixed-dose combination compared with individual components: A phase 1, open-label, single-dose study

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.209 ◽

2015 ◽

Vol 5 (2) ◽

pp. 109-117 ◽

Cited By ~ 6

Author(s):

Rainard Fuhr ◽

Anne Leselbaum ◽

Jordi Aubets

Keyword(s):

Single Dose ◽

Phase 1 ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Open Label ◽

Single Dose Study ◽

Dose Study ◽

Aclidinium Bromide ◽

Dose Combination ◽

Formoterol Fumarate

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A Phase 1, Open‐Label, Parallel‐Group, Single‐Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1412 ◽

2019 ◽

Vol 59 (8) ◽

pp. 1110-1119 ◽

Cited By ~ 21

Author(s):

Lesley Taylor ◽

Julie Crockett ◽

Bola Tayo ◽

Gilmour Morrison

Keyword(s):

Single Dose ◽

Hepatic Impairment ◽

Phase 1 ◽

Severe Hepatic Impairment ◽

Open Label ◽

Parallel Group ◽

Dose Trial

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Single-center, phase i, open label, single dose study to evaluate the pharmacokinetics and safety of wck 2349 in patients with hepatic impairment

10.26226/morressier.56d6be7ad462b80296c97cf9 ◽

2016 ◽

Author(s):

Richard Preston

Keyword(s):

Single Dose ◽

Phase I ◽

Hepatic Impairment ◽

Single Center ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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1027-P: A Phase 1, Open-Label, Single-Dose Study to Evaluate Pharmacokinetics of MEDI0382 in Patients with Renal Impairment

Diabetes ◽

10.2337/db19-1027-p ◽

2019 ◽

Vol 68 (Supplement 1) ◽

pp. 1027-P

Author(s):

GERNOT K. KLEIN ◽

MARCELLA PETRONE ◽

YE YANG ◽

THUONG HOANG ◽

SHEILA DICOSTANZA ◽

...

Keyword(s):

Single Dose ◽

Renal Impairment ◽

Phase 1 ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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An open-label, single-dose study to assess the effect of hepatic impairment on the pharmacokinetics of mirogabalin

Journal of Pain ◽

10.1016/j.jpain.2017.12.168 ◽

2018 ◽

Vol 19 (3) ◽

pp. S74

Author(s):

K. Duchin ◽

G. Senaldi ◽

V. Warren ◽

J. Lee ◽

T. Marbury ◽

...

Keyword(s):

Single Dose ◽

Hepatic Impairment ◽

Open Label ◽

Single Dose Study ◽

Dose Study

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