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References / Publications

Trials with hepatically impaired subjects

Single-dose pharmacokinetics of repaglinide in subjects with chronic liver disease
V Hatorp (Novo Nordisk), K H Walther, M S Christensen, G Haug-Pihale (APEX)
J Clin Pharmacol , 2000 Feb;40(2):142-52

Pharmacokinetics in renally impaired subjects of NXY-059, a nitrone-based, free-radical trapping agent developed for the treatment of acute stroke
S Strid (Astra Zeneca), O Borga, Ch Edenius, K-G Jostell, T Odergren, A Weil (APEX)
Eur J Clin Pharmacol (2002) 58: 409–415

The effects of age and renal and hepatic impairment on the pharmacokinetics of sildenafil citrate
G J  Muirhead (Pfizer), K Wilner, W Colburn, G Haug-Pihale (APEX), B Rouviex
Br J Clin Pharmacol (2002), 53: 21-30

Pharmacokinetics and sedative effects in healthy subjects and subjects with impaired liver function after continuous infusion of clomethiazole
C Centerholt (Astra Zeneca), M Ekblom, T Odergren, O Borgå, G Popescu, KH Molz, A Couturier, A Weil (APEX)
Eur J Clin Pharmacol. 2003 Jun;59(2):117-22. Epub 2003 May 7

Influence of Mild Liver lmpairment on the Pharmacokinetics and Metabolism of Bosentan, a Dual Endothelin Receptor Antagonist
P L M. van Giersbergen, G Popescu (APEX), F Bodin, J Dingemanse
J Clin Pharmacol (2003) 43: 15-22

The effects of hepatic impairment on the pharmacokinetics of fosfluconazole and fluconazole following a single intravenous bolus injection of fosfluconazole
S Sobue, K Tan, G Haug-Pihale (APEX)

Br J Clin Pharmacol (2004) 59 (2): 160–166
Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate
P Snell (Roche), N Dave, K Wilson, L Rowell, A Weil (APEX), L Galitz, R Robson
Br J Clin Pharmacol (2005) 59 (5): 598–601

The Pharmacokinetics of Escitalopram in Patients With Hepatic Impairment
J Areberg (Lundbeck), J Strøyer Christophersen , M Nøhr Poulsen , F Larsen,  KH Molz (APEX)
The AAPS Journal 2006; 8 (1) Article 2

Pharmacokinetics, safety and tolerability of a single oral dose of maraviroc in HIV-negative subjects with mild and moderate hepatic impairment
S Abel (Pfizer), J D Davis, C E Ridgway, J C Hamlin, M Vourvahis - (Trial conducted at APEX 2006) -
Antiviral Therapy (2009) 14:831–837

The influence of hepatic impairment on the pharmacokinetics of Paliperidone
S Boom (Johnson & Johnson), A Thyssen, H Crauwels, KH Molz (APEX), A Cleton, L Janssens, K Talluri, M Eerdekens
Int J Clin Pharmacol Ther. 2009 Oct;47(10):606-16

Effects of Hepatic Impairment on the Steady-State Pharmacokinetics of Etravirine 200 mg BID: An Open-Label,Multiple-Dose, Controlled Phase I Study in Adults
M Schöller-Gyüre (Tibotec), T N Kakuda, G De Smedt, B Woodfall, C Berckmans, M Peeters, R M W Hoetelmans - (Trial conducted at APEX 2006) -
Clin Therapeutics (2010) 32 (2): 328-337

Pharmacokinetics of vandetanib in subjects with renal or hepatic impairment
A Weil ( APEX), P Martin, R Smith, S Oliver, P Langmuir, J Read, KH Molz (APEX)
Clin Pharmacokinet. (2010) 49 (9): 607-18

Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics and Safety of Carisbamate
K Moore (Johnson & Johnson), P Zannikos, B Solanki, A Greenspan, T Verhaeghe, H R Brashear - (Trial conducted at APEX 2006) –
J Clinical Pharmacol (2012) 52:738-746

Pharmacokinetics and Safety of Boosted Elvitegravir in Subjects with Hepatic Impairment
J M Custodio (Gilead Sciences), M Rhee, G Shen, K H J Ling, B P Kearney, S Ramanathan - (Trial conducted at APEX 2010)-
Antimicrobial Agents and Chemotherapy   (2014) 58 (5): 2564 -2569

Pharmacokinetics and Safety of Aclidinium Bromide, a Muscarinic Antagonist, in Adults With Normal or Impaired Renal Function:              A Phase II, Open-Label, Single-Dose Clinical Trial
K Schmid (APEX), S Pascual, E Garcia Gil, S Ortiz, JM Jansat
Clin. Ther. (2010) 32: 1798-1812

Pharmacokinetics of JNJ-73763989 and JNJ-56136379 (bersacapavir) in participants with moderate hepatic impairment
TN. Kakuda, A Halabi, G Klein (APEX), M Sanga, C Guinard-Azadian, M Kowalik, K Nedoschinsky, J Nangosyah, E Njumbe Ediage, V Hillewaert, P Verboven, I Goris, J Snoeys, M Palmer, M Biermer

Effect of Severe Renal Impairment on Pharmacokinetics, Safety, and Tolerability of ACT-1014-6470, a Novel Oral Complement Factor 5a Receptor 1 Antagonist
A Hammann-Hänni, P Kaufmann, G Klein (APEX), K Schmid (APEX), J Dingemanse
Clinical Pharmacology in Drug Development (2022), 0(0) 1–7