Trial Condition(s):

Clinical Pharmacology

Phase I Multiple dose escalation study

Bayer Identifier:

13785

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-021029-11

Study Completed

Trial Purpose

Primary objective: To investigate the safety and tolerability of BAY 94-8862 after multiple oral doses of 10 mg twice a day (bid), 20 mg bid and 40 mg once a day given as 10 mg immediate release tablets over 10 days in 12 healthy male subjects (9-verum and 3 placebo) per dose step in a randomized, single-blind, placebo-controlled, group-comparison design.
Secondary objectives: To assess
- The pharmacodynamics of BAY 94-8862 and pharmacokinetics (PK) of BAY 94-8862 and three metabolites
- The influence of multiple oral doses of BAY 94-8862 given as 20 mg bid over 10 days on the PK of a single oral dose of the CYP3A4 substrate midazolam in 9 healthy male subjects.

Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age, body mass index ( ≥ 18.0 and ≤ 29.9 kg/m²
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 electrocardiography, physical 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 drugs, 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, especially concomitant administration of potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, nonsteroidal anti-inflammatory drugs like acetylsalicylic acid, indomethacin or ibuprofen, concomitant use of strong CYP3A4 inducers and inhibitors, weak to moderate CYP3A4 inhibitors
 - Subjects testing positive in the drug screening
 - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
 - Serum potassium level greater than equal to 5.0 mmol/L, serum sodium level less than equal to 130 mmol/L
 - History of myasthenia gravis, narrow angle glaucoma
 - Known sleep apnea syndrome 
 - Known hereditary galactose intolerance, lactase deficiency or glucose-galactase deficiency
 - Regular intake of liquorice or intake of liquorice within the last 14 days prior study treatment

Trial Summary

Enrollment Goal
47
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42096

Status
Completed
 

Trial Design