check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
14508
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
BAY94-8862, Age and Gender Study
Trial purpose
Primary objective: To investigate the influence of age and gender on the pharmacokinetics of BAY 94-8862 given as a 10 mg immediate-release tablet single dose in young and elderly healthy male and female subjects (of non-childbearing potential)
Secondary objectives: To assess safety and tolerability of BAY 94-8862
Secondary objectives: To assess safety and tolerability of BAY 94-8862
Key Participants Requirements
Sex
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
48Trial Dates
February 2011 - September 2011Phase
Phase 1Could I Receive a placebo
YesProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Köln, 51063, Germany |
Primary Outcome
- AUC: Area under the concentration vs time curve from zero to infinity after single dose for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- AUCnorm: AUC divided by dose per body weight for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax: Maximum observed drug concentration in plasma after single dose administration for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax,norm: Cmax divided by dose per body weight for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUC/D: AUC divided by dose for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax/D: Cmax divided by dose for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- tmax: Time to reach Cmax in plasma after single dose for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- t½: Half-life associated with the terminal slope for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- MRT: Mean residence time for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- CL/F: Total body clearance of drug calculated after extravascular administration (apparent oral clearance in this study) for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Vz/F: Apparent volume of distribution during terminal phase after extravascular administration for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-tlast): AUC from time 0 to the last data point > lower limit of quantification for BAY 94-8862date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Heart rate over 1 mindate_rangeTime Frame:From 24 h prior to dosing to 4 h post-doseenhanced_encryptionNoSafety Issue:
- Neurohormones: Plasma renin activity, angiotensin II, and aldosteronedate_rangeTime Frame:From 24 h prior to dosing to 24 h post-doseenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 5 weeksenhanced_encryptionYesSafety Issue:
- HR: Heart ratedate_rangeTime Frame:Approximately 5 weeksenhanced_encryptionYesSafety Issue:
- BP: Blood pressuredate_rangeTime Frame:Approximately 5 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
5