Trial Condition(s):
Clinical Pharmacology
BAY1021189, Omeprazol/Antacida Interaction Study
Bayer Identifier:
15811
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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 one time co-treatment of 2 x 20 mg Antra® once daily on the pharmacokinetics of 5 mg BAY 1021189 in comparison to 5 mg BAY 1021189 alone, both given orally as 4 x 1.25 mg immediate release tablets, in a three-fold crossover, randomized, open label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 1021189.
Inclusion Criteria
- Healthy, white male subjects, 18 to 45 years of age, body mass index: between ≥18.0 and ≤29.9 kg/m2
Exclusion Criteria
- 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 - Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal - Recent donation of blood/blood components - Clinically relevant changes/deviations from normal ECG, 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 - Subjects testing positive in the drug screening - Positive urine drug screening - Special diets preventing the subjects from eating the standard meals during the study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Wuppertal, Germany, 42096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4 days pre- and co-treatment with Antra® 2 x 20 mg OD, respectively, on the pharmacokinetics of a single dose of 5 mg BAY 1021189, taken as 4 x 1.25 mg IR tablets, in a threefold crossover, randomized, open label design in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- AUCArea under the plasma concentration vs time curve from zero to infinity after single (first) doseTimeframe: Pre-dose and up to 72 h post administration
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: Pre-dose and up to 72 h post administration
- Cmax/C(24h)Ratio of maximum drug concentration in plasma after single dose administration and drug concentration at 24 h post dosingTimeframe: Pre-dose and up to 72 h post administration
Secondary Outcome
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)Timeframe: Pre-dose and up to 72 h post administration
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Pre-dose and up to 72 h post administration
- t½Half-life associated with the terminal slopeTimeframe: Pre-dose and up to 72 h post administration
- AUC/DAUC divided by dose (mg)Timeframe: Pre-dose and up to 72 h post administration
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)Timeframe: Pre-dose and up to 72 h post administration
- CL/fTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Pre-dose and up to 72 h post administration
- AUC(0-tlast)AUC from time 0 to the last data pointTimeframe: Pre-dose and up to 72 h post administration
- Number of participants with adverse eventsTimeframe: Approximately eight weeks
Additional Information
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