check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14506

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-023064-40

EU CT Number:

Not Available
BAY94-8862, Interaction Study with Ompeprazole and Maalox

Trial purpose

Primary objective: To investigate
-   The influence of a co-administration of a single dose of 10 mL Maalox 70 mVal suspension and
-   A 4-day pre- and co-treatment of 40 mg omeprazole once daily (given as 2 x 20 mg Antra)
on the pharmacokinetics of BAY 94-8862 given as a 10 mg immediate release tablet single dose in comparison to a single oral dose of 10 mg BAY 94-8862 alone in a 3-fold crossover, randomized, open-label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.

Key Participants Requirements

Sex

Male

Age

18 - 46 Years
  • - Healthy male white subjects; 18 to 46 years of age; body mass index ≥18 and ≤29.9 kg/m*2.

  • - Recent donation of blood/blood components - Subjects hypersensitive to investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies
    - Galactose and fructose intolerance
    - Lactase, saccharase-isomaltase or vitamin B12 deficiency, hypo- or hyperchlorhydria, hypophosphatemia, porphyria
    - Medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results - Positive testing in drug screening - Subject is tested to be human immunodeficiency virus 1/2 antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies positive - Clinically relevant changes/deviations from normal range in electrocardiogram, clinical examination, clinical chemistry, hematology, urinalysis, serum potassium ≥5.0 mmol/L, serum sodium ≤130 mmol/L, and/or vital signs (blood pressure, heart rate) - Regular daily consumption of a certain amount of beer, alcohol, cigarettes, xanthine or grapefruit-containing beverages that may affect study results - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study which could have interfered with the investigational product; especially concomitant use of: Potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, non-steroidal anti-inflammatory drugs, strong CYP3A4 inducers, Weak to moderate CYP3A4 inhibitors, strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8, macrolide antibiotics, digoxin, warfarin, terfenadine,
    astemizole, cyclosporine, cisapride, tacrolimus or atazanavir, prokinetic or anticholinergic drugs

Trial summary

Enrollment Goal
12
Trial Dates
November 2010 - February 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Köln, 51063, Germany

Primary Outcome

  • AUC: Area under the plasma concentration versus time curve from zero to infinity after single dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax: Maximum drug concentration in plasma after single dose administration for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUCnorm: Area under the curve divided by dose per body weight for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D: AUC divided by dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm: Maximum drug concentration in plasma after single dose administration divided by dose per body weight for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D: Maximum drug concentration in plasma after single dose administration divided by dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax: Time to reach maximum drug concentration in plasma after single dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t½: Half-life associated with the terminal slope for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • MRT: Mean residence time for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CL/f: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn): AUC from zero to the last data point for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose up to 36 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Heart rate
    date_rangeTime Frame:
    At screening, from -0d14h00m through 2d00h00m of each treatment period and at follow-up
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Blood pressure
    date_rangeTime Frame:
    At screening, from -0d14h00m through 2d00h00m of each treatment period and at follow-up
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4-day pre- and co-treatment with omeprazole 40 mg OD, respectively, on the pharmacokinetics of a single dose of 10 mg BAY 94-8862 IR-tablet in a threefold crossover, randomized, open-label design in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3