Arvid Jungnik

Assessing the Effect of Food on the Pharmacokinetics of Iclepertin in Healthy Volunteers: A Phase I, Open-Label, Randomised, Cross-over Trial

Shilpa Madari, Kerstin Breithaupt-Groegler, Brett A. English, Kathrin Hohl et autres

Iclepertin, a selective glycine transporter-1 inhibitor, was investigated as a potential treatment for cognitive impairment associated with schizophrenia. The objective of this trial was to determine the effect of food on the pharmacokinetics of iclepertin 10 mg. This Phase I, open-label, 2-period …

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THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF ICLEPERTIN (BI 425809), A GLYCINE TRANSPORTER 1 INHIBITOR, IN HEALTHY VOLUNTEERS: A PHASE I OPEN-LABEL, RANDOMIZED, CROSSOVER TRIAL

Akiko Harada, Shilpa Madari, Arvid Jungnik, Kerstin Breithaupt-Groegler et autres

Abstract Background Iclepertin (BI 425809) is a glycine transporter 1 inhibitor being developed for the treatment of cognitive impairment associated with schizophrenia (CIAS). Aims and Objectives To investigate the effect of food on the pharmacokinetics (PK) of iclepertin in healthy volunteers (HV). …

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Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist BI 456906

Arvid Jungnik, Jorge Arrubla, Leona Plum‐Mörschel, Christoph Kapitza et autres

Abstract Aim To report two phase I studies of the novel subcutaneous glucagon‐like peptide‐1 receptor/glucagon receptor (GLP‐1R/GCGR) dual agonist BI 456906 versus placebo in healthy volunteers and people with overweight/obesity. Materials and Methods A phase Ia study (NCT03175211) investigated single rising doses …

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Author response for "Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon‐like peptide‐1 receptor ( GCGR / GLP‐1R ) agonist BI 456906"

Arvid Jungnik, Jorge Arrubla, Leona Plum‐Mörschel, Christoph Kapitza et autres

Safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of BI 187004, an inhibitor of 11beta-hydroxysteroid dehydrogenase-1, in healthy male volunteers with overweight or obesity

Susanna Bianzano, Tim Heise, Arvid Jungnik, Cornelia Schepers et autres

BACKGROUND: The study characterizes safety, tolerability, pharmacokinetic and pharmacodynamic profiles of single rising doses of the 11beta-hydroxysteroid dehydrogenase-1 (11beta-HSD1) inhibitor BI 187004 in healthy men with overweight or obesity. METHODS: This was a randomized, double-blind, parallel group, placebo-controlled study with administration of …

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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Bi 187004, an Inhibitor of 11beta-hydroxysteroid Dehydrogenase-1, in Healthy Male Volunteers With Overweight or Obesity

Susanna Bianzano, Tim Heise, Arvid Jungnik, Cornelia Schepers et autres

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Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects

Doreen Luedtke, Kristell Marzin, Arvid Jungnik, Ute von Wangenheim et autres

Nintedanib is a substrate for p-glycoprotein which can impact bioavailability. We investigated the effects of ketoconazole, a p-glycoprotein inhibitor, and rifampicin, a p-glycoprotein inducer, on the pharmacokinetics of nintedanib. In the ketoconazole study, 34 healthy subjects received nintedanib 50 mg orally alone …

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Effects of Metformin and Furosemide on Rosuvastatin Pharmacokinetics in Healthy Volunteers: Implications for Their Use as Probe Drugs in a Transporter Cocktail

Peter Stopfer, Thomas Gießmann, Kathrin Hohl, Ashish Sharma et autres

In a recently described probe drug cocktail for clinically relevant drug transporters containing digoxin, furosemide, metformin and rosuvastatin, mutual interactions were essentially absent except for increases in the systemic exposure of rosuvastatin. To optimize the cocktail, we further examined the dose dependence …

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Safety, pharmacokinetics and pharmacodynamics of BI 135585, a selective 11β‐hydroxysteroid dehydrogenase‐1 ( HSD1 ) inhibitor in humans: liver and adipose tissue 11β‐ HSD1 inhibition after acute and multiple administrations over 2 weeks

Susanna Freude, Tim Heise, Hans Juergen Woerle, Arvid Jungnik et autres

AIMS: To assess the safety and pharmacokinetic and pharmacodynamic characteristics of BI 135585, a selective 11β-hydroxysteroid dehydrogenase-1 (11β-HSD1) inhibitor, after single- and repeated-dose administration. METHODS: The single-dose study included open-label administration of 200 mg BI 135585 in healthy volunteers, while in the …

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Biotransformation and mass balance of the SGLT2 inhibitor empagliflozin in healthy volunteers

Linzhi Chen, Arvid Jungnik, Yan‐Ping Mao, Elsy Philip et autres

1. The absorption, biotransformation and excretion of empagliflozin, an SGLT2 inhibitor, were evaluated in eight healthy subjects following a single 50 mg oral dose of empagliflozin containing ∼100 µCi [(14)C]-empagliflozin. 2. Radioactivity was rapidly absorbed, with plasma levels peaking 1 h post-dose. …

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Effect of food and tablet-dissolution characteristics on the bioavailability of linagliptin fixed-dose combination with metformin: evidence from two randomized trials

Katrin Metzmann, David Schnell, Arvid Jungnik, Arne Ring et autres

OBJECTIVE: The objectives of the studies reported here were to determine the relative bioavailability of linagliptin and metformin when administered in a fixed-dose combination (FDC) tablet with and without food, and to investigate the relative bioavailability of linagliptin and metformin FDC tablets …

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Pharmacokinetic Drug Interactions of Afatinib with Rifampicin and Ritonavir

Sven Wind, Thomas Gießmann, Arvid Jungnik, Tobias Brand et autres

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