Trial Condition(s):

Clinical Pharmacology

BAY94-8862, 3A4 Inhibitor erythromycim study

Bayer Identifier:

14504

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000736-25

Study Completed

Trial Purpose

Primary objective: To investigate the influence of multiple oral doses of 500 mg erythromycin tid on the safety, tolerability, pharmacodynamics, and pharmacokinetics of 1.25 mg BAY 94-8862 given as a single oral dose in comparison to 1.25 mg BAY 94-8862 given alone.

Inclusion Criteria
- Healthy male white subjects; 18 to 46 years of age; body mass index ≥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 ECG, 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 study drug or interacting drug, the control agent and/or to inactive constituents, especially hypersensitivity to macrolides antibiotics
 - Regular use of therapeutic or recreational drugs, eg carnitine products, anabolics, high-dose vitamins
 - 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
 -  Comedication with antihistamines, cisapride or pimozide, colistin, chloramphenicol, clindamycin, lincomycin, streptomycin or other tetracyclines, and medicines, which are known to prolong the QT interval
 - Subjects testing positive in the drug screening
 - Suspicion of drug abuse, including alcohol abuse
 - 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
16
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Köln, Germany, 51063

Status
Completed
 

Trial Design