Trial Condition(s):
Clinical Pharmacology
BAY94-8862, Single dose titration study
Bayer Identifier:
13782
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Healthy male white subjects; 18 to 45 years of age; body mass index between 18 and 29.9 kg/m*2.
Exclusion Criteria
- Subjects with conspicuous findings in medical history and pre-study examination - Recent donation of blood/blood components - Clinically relevant changes/deviations from normal electrocardiogram values, clinical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs) - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, foods or beverages containing grapefruit and/or cigarettes that may affect study results - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions that would impair subject’s ability to participate in the trial or that may affect study results - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study which could interfere with the investigational product - Concomitant administration of potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory drugs or potassium supplements - History of peptic ulcers or relevant gastro-esophageal reflux disease - Subjects testing positive in the drug screening - History of substance abuse, including alcohol abuse or dependence - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
Trial Summary
Enrollment Goal
45
Trial Dates
Phase
1
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Wuppertal, Germany, 42096 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Single dose, basic phase I dose escalation study in a randomized, single-blind, placebo-controlled, group-comparison design to investigate safety and tolerability of BAY 94-8862 and its pharmacodynamics and pharmacokinetics after oral dosing in 8 healthy male subjects per dose step
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
7
Primary Outcome
- AUC: Area under the plasma concentration versus time curve from zero to infinity after single doseTimeframe: Pre-dose and up to 72 h post-dose
- Cmax: Maximum drug concentration in plasma after single dose administrationTimeframe: Pre-dose and up to 72 h post-dose
Secondary Outcome
- AUC/D: AUC divided by doseTimeframe: Pre-dose and up to 72 h post-dose
- AUCnorm: Area under the curve divided by dose per body weightTimeframe: Pre-dose and up to 72 h post-dose
- Cmax/D: Maximum drug concentration in plasma after single dose administration divided by doseTimeframe: Pre-dose and up to 72 h post-dose
- Cmax,norm: Maximum drug concentration in plasma after single dose administration divided by dose per body weightTimeframe: Pre-dose and up to 72 h post-dose
- tmax: Time to reach maximum drug concentration in plasma after single doseTimeframe: Pre-dose and up to 72 h post-dose
- t½: Half-life associated with the terminal slopeTimeframe: Pre-dose and up to 72 h post-dose
- MRT: Mean residence timeTimeframe: Pre-dose and up to 72 h post-dose
- CL/f: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Pre-dose and up to 72 h post-dose
- Vz/f: Apparent volume of distribution during terminal phase after oral administrationTimeframe: Pre-dose and up to 72 h post-dose
- AUC(0-tn): AUC from zero to the last data pointTimeframe: Pre-dose and up to 72 h post-dose
- Aeur: Amount of drug excreted via urine (only in the 40 mg dose step)Timeframe: Pre-dose and up to 72 h post-dose
- CLR: Renal clearance (only in the 40 mg dose step)Timeframe: Pre-dose and up to 72 h post-dose
- BP: Blood pressureTimeframe: Approximately 4 weeks
- HR over 1 min: Heart rate over 1 minTimeframe: From 24 h prior to dosing to 24 h post-dose
- Standing BP: Standing blood pressureTimeframe: 22 h prior to dosing to 4 h post-dose
- Neurohormones: Plasma renin activity, serum angiotensin II, serum aldosterone, and serum noradrenalineTimeframe: From 24 h prior to dosing to 24 h post-dose
- 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 ratioTimeframe: From 24 h prior to dosing to 24 h post-dose
- Number of participants with adverse eventTimeframe: Approximately 4 weeks
- HR: Heart rateTimeframe: Approximately 4 weeks
Additional Information
Not Available
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