Trial Condition(s):
Clinical Pharmacology
Relative bioavailability and food interaction study of BAY1021189
Bayer Identifier:
15356
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Primary objectives:
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
Secondary objectives:
- Safety, tolerability and pharmacodynamics of BAY 1021189.
Inclusion Criteria
- Healthy white male volunteers, age 18-45 years, body mass index: ≥ 18 and ≤ 29.9 kg/m²
Exclusion Criteria
- 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 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 - Subjects testing positive in the drug screening - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not be normal - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody - Special diets preventing the subjects from eating the standard meals during the study - History of postural syncopes
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, 42113 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Relative bioavailability study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of 1.25 mg and 5 mg BAY 1021189 IR tablets in comparison to 5 mg oral solution, and to investigate the influence of a high fat, high calorie meal on the 5 mg IR tablet in 16 healthy male subjects in a single dose, randomized, open-label, four-fold cross-over design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- Number of participants with adverse eventsTimeframe: Approximately 8 weeks
- BPBlood pressureTimeframe: Approximately 8 weeks
- HR over 1 minHeart rate over 1 minTimeframe: Pre-dose and up to 24 h post-dose
- Plasma cGMPPlasma cyclic guanosine monophosphateTimeframe: Pre-dose and up to 24 h post-dose
- Impedance cardiographyThe following variables were measured: stroke volume, cardiac output, heart rate, cardiac indexTimeframe: Pre-dose and up to 8 h post-dose
- HRHeart rateTimeframe: Approximately 8 weeks
- AUCArea under the plasma concentration vs time curve from zero to infinity after single doseTimeframe: From pre-dose up to 72 h post-dose
- AUC/DAUC divided by dose (mg)Timeframe: From pre-dose up to 72 h post-dose
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)Timeframe: From pre-dose up to 72 h post-dose
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: From pre-dose up to 72 h post-dose
Secondary Outcome
- AUCnormArea under the curve divided by dose per kg body weightTimeframe: From pre-dose up to 72 h post-dose
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightTimeframe: From pre-dose up to 72 h post-dose
- tmaxTime to reach maximum drug concentration in plasma after single doseTimeframe: From pre-dose up to 72 h post-dose
- t½Half-life associated with the terminal slopeTimeframe: From pre-dose up to 72 h post-dose
- CL/FTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: From pre-dose up to 72 h post-dose
- Vz/FApparent volume of distribution during terminal phase after oral administrationTimeframe: From pre-dose up to 72 h post-dose
Additional Information
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