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Clinical Trial Details

Trial ID: L0289
Source ID: NCT01679587
Associated Drug: Molidustat (Bay85-3934)
Title: Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Diseases
Interventions: DRUG: Molidustat (BAY85-3934)|DRUG: Placebo
Outcome Measures: Primary: Number of participants with adverse events, Approximately 9 weeks|Blood pressure, Systolic, diastolic, mean blood pressure, Approximately 9 weeks|Heart rate, Approximately 9 weeks|Cmax, Maximum observed drug concentration in measured matrix after single dose administration, Pre-dose and up to 48 h post-dose|Cmax/D, Cmax divided by dose, Pre-dose and up to 48 h post-dose|AUC, Area under the concentration vs time curve from zero to infinity after single dose, Pre-dose and up to 48 h post-dose|AUC/D, AUC divided by dose, Pre-dose and up to 48 h post-dose|Heart rate over 1 min, Pre-dose and up to 24 h post-dose|Standing blood pressure procedure, Starting from 2 h post-dose and up to 4 h post-dose|Impedance cardiography, Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance, Pre-dose and up tp 8 h post-dose | Secondary: Change of hematology profile, Hematology profile includes blood concentration of erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit, and exploratory biomarkers., From baseline to Day 1 after single dose|Cmax,norm, Cmax divided by dose per body weight, Pre-dose and up to 48 h post-dose|AUCnorm, AUC divided by dose per body weight, Pre-dose and up to 48 h post-dose|AUC(0-24), AUC from 0 until 24 h after study drug administration, Pre-dose and up to 24 h post-dose|AUC(0-tlast), AUC from time 0 to the last data point \> lower limit of quantification, Pre-dose and up to 48 h post-dose|t½, Half-life associated with the terminal slope, Pre-dose and up to 48 h post-dose|tmax, Time to reach Cmax (in case of two identical Cmax values, the first tmax was used), Pre-dose and up to 48 h post-dose|MRT, Mean residence time, Pre-dose and up to 48 h post-dose|CL/F, Total body clearance of drug calculated after extravascular administration (eg, apparent oral clearance), Pre-dose and up to 48 h post-dose|Vz/F, Apparent volume of distribution during terminal phase after extravascular administration, Pre-dose and up to 48 h post-dose|Geometric mean erythropoietin Cmax, Pre-dose and up to 24 h post-dose|Geometric mean reticulocyte count, Pre-dose and up to 24 h post-dose|Geometric mean erythrocyte count, Pre-dose and up to 24 h post-dose|Geometric mean reticulocytes/erythrocytes values, Pre-dose and up to 24 h post-dose|Geometric mean hemoglobin values, Pre-dose and up to 24 h post-dose|Geometric mean hematocrit, Pre-dose and up to 24 h post-dose|Geometric mean erythropoietin tmax, Pre-dose and up to 24 h post-dose|Geometric mean erythropoietin AUC(0-24), Pre-dose and up to 24 h post-dose
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose:
Start Date: 2012-09
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2016-05-02
Locations: München, Bayern, 81241, Germany|Mönchengladbach, Nordrhein-Westfalen, 41061, Germany|Kiel, Schleswig-Holstein, 24105, Germany
URL: https://clinicaltrials.gov/show/NCT01679587