Who is APEX ?

APEX Research is a Munich-based independent contract research organization. Since 1994, we are conducting regulatory pharmaceutical studies on behalf of the pharmaceutical industry on our own 12-bed trial unit.
Our research focus is on pharmacokinetic studies examining the influence of impaired liver or kidney function on the metabolism and excretion of pharmaceuticals. Accordingly, we primarily work with patients suffering from compromised liver or kidney function, up to and including dialysis. In addition, we also conduct pharmaceutical studies with other patient groups (e.g. diabetes, hypertension, COPD). We are able to contribute our years of experience in the field of clinical research to each new project.

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