check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
13782
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
BAY94-8862, Single dose titration study
Trial purpose
Primary objective: To investigate the safety and tolerability of BAY 94-8862 after single oral doses starting at 1.0 mg administered as a polyethylene glycol based solution in healthy male subjects. While doses up to 40 mg were planned, the maximum dose depended on the safety, tolerability, and pharmacokinetic results of the previous dose step.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
45Trial Dates
August 2009 - April 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wuppertal, 42096, Germany |
Primary Outcome
- AUC: Area under the plasma concentration versus time curve from zero to infinity after single dosedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax: Maximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUC/D: AUC divided by dosedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- AUCnorm: Area under the curve divided by dose per body weightdate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax/D: Maximum drug concentration in plasma after single dose administration divided by dosedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax,norm: Maximum drug concentration in plasma after single dose administration divided by dose per body weightdate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- tmax: Time to reach maximum drug concentration in plasma after single dosedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- t½: Half-life associated with the terminal slopedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- MRT: Mean residence timedate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- CL/f: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Vz/f: Apparent volume of distribution during terminal phase after oral administrationdate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-tn): AUC from zero to the last data pointdate_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Aeur: Amount of drug excreted via urine (only in the 40 mg dose step)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- CLR: Renal clearance (only in the 40 mg dose step)date_rangeTime Frame:Pre-dose and up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- BP: Blood pressuredate_rangeTime Frame:Approximately 4 weeksenhanced_encryptionYesSafety Issue:
- HR over 1 min: Heart rate over 1 mindate_rangeTime Frame:From 24 h prior to dosing to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Standing BP: Standing blood pressuredate_rangeTime Frame:22 h prior to dosing to 4 h post-doseenhanced_encryptionYesSafety Issue:
- Neurohormones: Plasma renin activity, serum angiotensin II, serum aldosterone, and serum noradrenalinedate_rangeTime Frame:From 24 h prior to dosing to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Urine: Urinary volume, sodium, potassium, magnesium, calcium, ratio of urinary sodium/ potassium, the log10 of urinary sodium/potassium ratio, and the log10 of 10*urinary sodium/potassium ratiodate_rangeTime Frame:From 24 h prior to dosing to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Number of participants with adverse eventdate_rangeTime Frame:Approximately 4 weeksenhanced_encryptionYesSafety Issue:
- HR: Heart ratedate_rangeTime Frame:Approximately 4 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
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