Silke Retlich

TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of BI 764198

Howard Trachtman, Matthias Kretzler, Loreto Gesualdo, Nicholas Cross et autres

us, it, nz, de, be, cn, au (code pays fourni par la source)

TRPC6 Inhibition for the Treatment of FSGS: Phase 2 Randomized Controlled Trial of BI 764198

Nicholas Cross, Howard Trachtman, Matthias Kretzler, Loreto Gesualdo et autres

Background: Focal segmental glomerulosclerosis (FSGS) is a relevant histopathological finding in individuals presenting with proteinuria, resulting in kidney failure in 50% within 5–10 years. In FSGS, transient receptor potential cation channel, subfamily-C, member-6 (TRPC6) overactivity may cause podocyte loss and progressive kidney …

nz, us, it, de, be, cn, au, br (code pays fourni par la source)

Population Pharmacokinetic and Exposure-Response Modeling Supports BI 764198 20 mg as the Therapeutic Dose for Phase 3, with No Dose Adjustment Required

Silke Retlich, Hendrik Maxime Lagraauw, Klas Petersson, Undine Falkenhagen et autres

Background: BI764198, a transient receptor potential cation channel, subfamily-C, member-6 (TRPC6) inhibitor, is being developed for the treatment of focal segmental glomerulosclerosis (FSGS). A comprehensive population pharmacokinetic (popPK) and exposure-response (E-R) analysis was conducted to inform dose selection and assess the impact …

de, se, br, us (code pays fourni par la source)

A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men

Takuma Yonemura, Akiko Sarashina, Yoshifumi Tachibana, Silke Retlich et autres

BACKGROUND: BI 764198 is a selective, oral transient receptor potential cation channel, subfamily C, member 6 inhibitor under investigation for focal segmental glomerulosclerosis. RESEARCH DESIGN AND METHODS: = 9) as a single dose then multiple daily dosing for 2 weeks. Primary endpoint: …

jp, ch, ph, ca, au, tw, us (code pays fourni par la source)

Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment

Armin Schultz, Atef Halabi, Friedeborg Seitz, Katrien Lemmens et autres

BACKGROUND: BI 764198 could reduce podocyte injury in focal segmental glomerulosclerosis (FSGS). RESEARCH DESIGN AND METHODS: Four Phase 1 BI 764198 trials: single rising dose (SRD) and multiple rising dose (MRD)/drug-drug interaction trials in healthy volunteers; relative bioavailability (rBA) study (food and …

de, au, tw, us (code pays fourni par la source)

Randomized, double-blind, placebo-controlled dose-finding study of the dipeptidyl peptidase-4 inhibitor linagliptin in pediatric patients with type 2 diabetes

William V. Tamborlane, Lori M. Laffel, Jacques Weill, Maud Gordat et autres

OBJECTIVE: To identify the dose of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in pediatric patients with type 2 diabetes (T2D). METHODS: Double-blind, randomized, controlled parallel group study comparing linagliptin 1 and 5 mg once daily, with placebo in 39 patients with T2D …

us, fr, Égypte, de (code pays fourni par la source)

Population Pharmacokinetics and Exposure–Response (Efficacy and Safety/Tolerability) of Empagliflozin in Patients with Type 2 Diabetes

Kyle T. Baron, Sreeraj Macha, Uli C. Broedl, Valerie Nock et autres

INTRODUCTION: The aim of the analysis was to characterize the population pharmacokinetics (PKs) and exposure-response (E-R) for efficacy (fasting plasma glucose, glycated hemoglobin) and safety/tolerability [hypoglycemia, genital infections, urinary tract infection (UTI), and volume depletion] of the sodium glucose cotransporter 2 inhibitor, …

us, de (code pays fourni par la source)

Mixed‐effects modelling to quantify the effect of empagliflozin on renal glucose reabsorption in patients with type 2 diabetes

John T. Mondick, Matthew M. Riggs, Tomohiro Sasaki, Akiko Sarashina et autres

AIMS: To quantify the effect of the sodium-glucose co-transporter 2 inhibitor, empagliflozin, on renal glucose reabsorption in patients with type 2 diabetes, and to evaluate covariate effects, using a mechanistic population pharmacokinetic-pharmacodynamic (PK-PD) model. METHODS: Four phase I/II trials were used for …

us, jp, de (code pays fourni par la source)

Population Pharmacokinetics and Pharmacodynamics of Linagliptin in Patients with Type 2 Diabetes Mellitus

Silke Retlich, Vincent Duval, Ulrike Graefe‐Mody, Christian Friedrich et autres

BACKGROUND AND OBJECTIVES: Linagliptin is a dipeptidyl peptidase (DPP)-4 inhibitor, used to treat type 2 diabetes mellitus (T2DM). Population pharmacokinetic and pharmacodynamic analyses were performed to characterize the impact of clinically relevant intrinsic/extrinsic factors (covariates) on linagliptin exposure and DPP-4 inhibition in …

de, gb, au (code pays fourni par la source)

Population Pharmacokinetic/Pharmacodynamic Analysis of the DPP-4 Inhibitor Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus

Yusuke Tadayasu, Akiko Sarashina, Yasuhiro Tsuda, Shinji Tatami et autres

OBJECTIVES: Linagliptin is a novel, highly selective and long acting DPP-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Linagliptin exhibits non-linear pharmacokinetics (PK) due to saturable binding to plasma and tissue DPP-4. The aim of this study was to …

ph, ch, de, jp (code pays fourni par la source)

Bioequivalence of Linagliptin 5 mg Once Daily and 2.5 mg Twice Daily: Pharmacokinetics and Pharmacodynamics in an Open-label Crossover Trial

Christian Friedrich, Arvid Jungnik, Silke Retlich, Arne Ring et autres

Linagliptin is an oral antihyperglycemic drug that acts by inhibiting the dipeptidyl peptidase-4 enzyme. A 5-mg once-daily regimen is available, but an alternative regimen was needed for twice-daily fixed-dose combinations. Although linagliptin has non-linear pharmacokinetics, simulation suggested 2.5 mg twice-daily would provide …

de (code pays fourni par la source)

Pharmacokinetic and pharmacodynamic evaluation of linagliptin in African American patients with type 2 diabetes mellitus

Christian Friedrich, Stephan Glund, Dominick A. Lionetti, Christian Kissling et autres

AIM: This was an open label, multicentre phase I trial to study the pharmacokinetics and pharmacodynamics of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in African American patients with type 2 diabetes mellitus (T2DM). METHODS: Forty-one African American patients with T2DM were included …

de, us, es, gb (code pays fourni par la source)